Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518486
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Foot-Ankle Exercise and Walking Exercise on Diabetes Mellitus Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Foot-Ankle Exercise and Walking Exercise on Foot Neuropathy Stress Quality of Life Blood Sugar Markers Blood Pressure Ankle-Brachial Index and BMI Among Diabetes Mellitus Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to determine the effectiveness of foot-ankle exercise and walking exercise on foot neuropathy stress and quality of life QoL among people with diabetes mellitus PWDM At the same time the secondary purpose of this study is to determine the effectiveness of foot-ankle exercise and walking exercise on body mass index BMI fasting blood glucose FBG blood pressure BP and ankle-brachial index ABI among PWDM at baseline before intervention0 week at 6-weeks and 12-weeks
The research questions in this study include the following
Is foot-ankle exercise effective for foot neuropathy stress QoL BMI FBG BP and ABI for PWDM
Is walking exercise effective for foot neuropathy stress QoL BMI FBG BP and ABI for PWDM
Are there any differences in the mean scores of foot neuropathy stress QoL BMI FBG BP and ABI of PWDM within and between the foot-ankle exercise walking exercise and control group at baseline 6 weeks and 12 weeks
Are there any mediatorsmoderators effect of BMI FBG blood pressure ABI and stress for influencing foot exercise and walking exercise interventions on foot neuropathy and QoL for PWDM
Participants in the foot-ankle exercise group will be given health education about DM and foot-ankle exercise as well as leaflets and videos Participants will be taught how to practice foot-ankle exercises before the instructor Afterwards participants will practice foot-ankle exercises independently without supervision for 2-3 sessions every day for 12 weeks Participants in the walking exercise group will be given health education about DM walking exercises and leaflets Participants will practice walking exercises independently without supervision for 12 weeks Participants are advised to do walking exercises with a minimum duration of 10 minutes for each session and 150 minutesweek Two consecutive days without walking exercise are not allowed Participants in the control groups will be treated as active control and given health education on general DM topics and leaflets All groups received usual care according to standards provided by public health services Researchers will compare the groups to see the effect of the interventions on foot neuropathy stress QoL BMI FBG BP and ABI at three different time points at baseline 6 weeks and 12 weeks
The research questions in this study include the following
Is foot-ankle exercise effective for foot neuropathy stress QoL BMI FBG BP and ABI for PWDM
Is walking exercise effective for foot neuropathy stress QoL BMI FBG BP and ABI for PWDM
Are there any differences in the mean scores of foot neuropathy stress QoL BMI FBG BP and ABI of PWDM within and between the foot-ankle exercise walking exercise and control group at baseline 6 weeks and 12 weeks
Are there any mediatorsmoderators effect of BMI FBG blood pressure ABI and stress for influencing foot exercise and walking exercise interventions on foot neuropathy and QoL for PWDM
Participants in the foot-ankle exercise group will be given health education about DM and foot-ankle exercise as well as leaflets and videos Participants will be taught how to practice foot-ankle exercises before the instructor Afterwards participants will practice foot-ankle exercises independently without supervision for 2-3 sessions every day for 12 weeks Participants in the walking exercise group will be given health education about DM walking exercises and leaflets Participants will practice walking exercises independently without supervision for 12 weeks Participants are advised to do walking exercises with a minimum duration of 10 minutes for each session and 150 minutesweek Two consecutive days without walking exercise are not allowed Participants in the control groups will be treated as active control and given health education on general DM topics and leaflets All groups received usual care according to standards provided by public health services Researchers will compare the groups to see the effect of the interventions on foot neuropathy stress QoL BMI FBG BP and ABI at three different time points at baseline 6 weeks and 12 weeks
Detailed Description:
Intervention Development
This study focused on foot-ankle exercises modified from previous research and adapted to exercises developed by the Indonesian Endocrinology Association Providing health education about DM in general and foot-ankle exercise is intended to increase participants basic knowledge about DM and the importance of foot-ankle exercises Foot-ankle exercise simulation and practice aim to ensure participants can do it well and independently The leaflet contains the material presented during health education and is given to participants A video was made containing the steps to do foot-ankle exercises Researchers will upload videos of the foot-ankle exercises to YouTube Participants will be given the video in soft file form and informed that they can access it via the researchers YouTube channel Walking exercises in this study adapted and modified from previous research Providing health education about DM in general and walking exercises is intended to increase participants basic knowledge about DM and the importance of walking exercise exercises The leaflet contains the material presented during health education and is given to participants in walking exercise groups
Content Validity
The content validity test in this study aims to validate the intervention procedures used during the research process The details are detail intervention of foot-ankle exercise and walking exercise health education materials and leaflets for the control group foot-ankle exercise groups and walking exercise groups videos of foot ankle exercises standard operational procedures for measuring foot sensation and foot vibration height and weight BP and ABI The criteria for Experts 1 Willing to be involved in the content validity study 2 Doctornurse 3 Have experience working in the clinical or research area on the topic of diabetes mellitus for more than 5 years In this study six experts are needed to achieve a content validation index CVI satisfaction of 083 Researchers will send formal invitations via email to experts The files include an application letter a cover letter containing the research objectives expert panel criteria intervention procedures to be assessed and an assessment sheet Assessment of each item uses a 1-4 Likert scale Item with score 3 will be asked to provide comments or suggestions to help further refine the intervention protocol Researchers will use item-level CVI I-CVI and the scale-level S-CVI The CVI value is satisfactory if I-CVI 080 and S-CVI 083 Items with a low CVI value will be revised according to the comments and suggestions of experts until the CVI value becomes satisfactory
Participants Recruitment Process
Researchers will ask the District Health Service for information about public health centers PHCs with active Chronic Disease Management Program PROLANIS activities Researchers will contact and collaborate with PHCs for participant recruitment The research team will contact each potential participant and explain the research process Researchers will also put-up posters in PHCs and also distribute these posters through social media Potential participants willing to become participants can contact the contacts listed on the poster For potential respondents who are willing after signing the informed consent they will be included in the chat group Participants will be given a transportation fee of IDR 25000 for each arrival during the data collection process
Sample Size Calculation
Samples were calculated using GPower sample size calculator v31 using F test with an analysis of variance based on some criteria Researchers will use small effect size 01 an α error probability of 005 and a power of 090 Number of groups 3 foot-ankle exercise walking exercise and control group and number of measurements 3 baseline 6-weeks and 12 weeks Based on the calculation 261 participants were needed and added an anticipated dropout of 20 55 people so the total sample size was 315 The total sample was divided into three groups each group had 105 participants
Randomization and Allocation Concealment
Eligible participants will be randomized by independent staff not involved in the recruitment and data collection process with a ratio of 111 for each group After baseline measurements the randomization process will be carried out using the computer-generated randomization method The method that will be used is random permuted blocks with size 3 6 9 The random numbers will be packaged in sequence stored and locked in opaque envelopes to guarantee allocation concealment This sequence will be kept private and stored in a place that assessors cannot access
Intervention Delivery
Control group The active control group was given health education on the topic of DM for 30 minutes and then given a leaflet
Foot-ankle exercise group Participants will be given health education on DM and foot-ankle exercise after the allocation procedure followed by simulation and practice lasts 60 minutes Participants were also given leaflets and videos to take home Afterward participants will practice independently without supervision for 12 weeks Foot-ankle exercise consists of 10 movements When doing foot exercises participants sit comfortably without leaning and the soles of their feet touch the floor and barefoot These movements are
A 1Lift the soles of the feet with heels still touching the floor2Toes are bent to grip like chicken claws in this position3Repeat this movement 10x
B 1Lift the soles of the feet with heels still touching the floor 2Lower the soles of feet and raise heels with toes touching the floor 3Repeat this movement 10x
C 1Lift the soles of the feet with heels still touching the floor2Do circular movements from the inside to the outside for the soles of both feet3Repeat this movement 10x
D 1Lift the heels of both feet with toes still touching the floor2Do circular movements from the inside to the outside for the soles of both feet3Repeat this movement 10x
E 1Lift right knee and straighten it The left leg remains in its original position2Move toes forward and backward3Repeat this movement 10x4Do the same for the left leg
F 1Lift right knee and straighten it2The left leg remains in its original position3Move toes towards face4Repeat this movement 10x5Do the same for the left leg
G 1Lift both knees of the right and left legs then straighten them2Move toes towards face at the same time3Repeat this movement 10x
H 1Lift both knees of the right and left legs then straighten them2Move both legs forward3Repeat this movement 10x
I 1Lift their right knee and straighten it The left leg remains in its original position2Write the numbers 1-10 with feet3Do the same movement for the left leg
J 1Place newspapers as a base for the soles2Shape the newspaper into a ball using both feet3Open the newspaper ball again to become sheet-like before using both feet4Divide the newspaper into two parts using both feet5Tear one part of the newspaper into small pieces and collect it on top of the other part of the newspaper6The newspaper sheet containing small shreds is made into a ball using both feet7Throw the newspaper ball into the trash
Walking exercise group Participants will be given health education for 30 minutes on DM and walking exercises and leaflet after the allocation procedure Participants will practice walking exercises independently for 12 weeks
Health education for all groups is provided by persons who have certificates as DM educators and carried out in subgroups with 7-10 members in each group To avoid contamination health education was implemented at different times Fridays for control group Saturday for foot-ankle exercise group and Sunday for walking exercise group with flexible implementation hours according to the agreement of each group All group participants were included in the chat group Whatsapp Messenger so that researchers could communicate and monitor the implementation of the intervention
Interventionist dan Outcome Investigators
Each research location has 1 health professional who carries out the intervention with criteria having a masters degree in nursing working as a health workerhealth educator for at least 5 years and having a certificate as a DM educator Each research location has at least of 1 outcome investigator with the criteria of a health worker with a registration certificate
Plan for Data ManagementAnalysis
Data analysis will use the intention to treat ITT principle In addition an analysis using the per-protocol PP principle will be carried out Then Researchers will compare the analysis results using ITT and PP and conduct a sensitivity test The data analysis process uses the SPSS V27 program Researchers will conduct a normality test using the Kolmogorov Smirnov test the data distribution is normal if the value is 005 Researchers will use the Generalized Estimating Equation GEE test to analyze changes in outcomes between the foot-ankle exercise group vs control group walking exercise group vs control group and foot-ankle exercise group vs walking exercise group over time baseline six weeks and 12 weeks Baseline measurement and control group as reference The significance value uses p value 005
Comparison data of baseline respondents between the 3 groups for categorical data will be analyzed by the Chi-squareFisher Exact test for numerical data ANOVA test for normal distributed or Friedman test for non-normally distributed If a significant imbalance is found an appropriate covariance adjustment analysis will be carried out in the data analysis Analysis within group for each measurement time baseline vs six weeks baseline vs 12 weeks six weeks vs 12 weeks will use the Paired T-test if normally distributed or the Wilcoxon test if non-normally distributed Meanwhile the analysis between groups for each measurement time T0 T1 and T2 will use the Independent T-test for normally distributed or the Mann-Whitney test for non-normally distributed
Researchers will use path analysis to analyze the mediationmoderator of BMI FBG BP ABI and stress on the effects of foot-ankle exercise and walking exercise on foot sensitivity and QoL The mediation analysis will use the bootstrap technique as a nonparametric procedure to test the statistical significance of various Partial Least Squares-Structural Equation Model PLS-SEM results such as path coefficients Researchers will use the software program SmartPLS 3 SmartPLS GmbH Bonningstedt Germany to analyze the mediation effects For PLS-SEM Standard Root Mean Square ResidualSRMR can be used as a goodness-of-fit test to prevent model specification errors SRMR is the difference between the observed correlation and the models implied correlation matrix As a result it is possible to use the average magnitude of the difference between measured and predicted correlations as an absolute measure of model goodness-of-fit A good fit is described as a value smaller than 010 or 008 The statistically significant level was set at 005 and 95 confidence intervals CI to test indirect effects The result indicates a significant level if the 95 CI does not contain zero
Monitor for Adverse Events
Adverse events that have the potential to occur include fatigue muscle aches pain and dizziness Participants will record for themselves if adverse events occur and report to the team The research team also monitored by telephone once a week asking whether any adverse events had occurred and recording them If excessive adverse events occur investigators will immediately stop the intervention and carry out treatment
This study focused on foot-ankle exercises modified from previous research and adapted to exercises developed by the Indonesian Endocrinology Association Providing health education about DM in general and foot-ankle exercise is intended to increase participants basic knowledge about DM and the importance of foot-ankle exercises Foot-ankle exercise simulation and practice aim to ensure participants can do it well and independently The leaflet contains the material presented during health education and is given to participants A video was made containing the steps to do foot-ankle exercises Researchers will upload videos of the foot-ankle exercises to YouTube Participants will be given the video in soft file form and informed that they can access it via the researchers YouTube channel Walking exercises in this study adapted and modified from previous research Providing health education about DM in general and walking exercises is intended to increase participants basic knowledge about DM and the importance of walking exercise exercises The leaflet contains the material presented during health education and is given to participants in walking exercise groups
Content Validity
The content validity test in this study aims to validate the intervention procedures used during the research process The details are detail intervention of foot-ankle exercise and walking exercise health education materials and leaflets for the control group foot-ankle exercise groups and walking exercise groups videos of foot ankle exercises standard operational procedures for measuring foot sensation and foot vibration height and weight BP and ABI The criteria for Experts 1 Willing to be involved in the content validity study 2 Doctornurse 3 Have experience working in the clinical or research area on the topic of diabetes mellitus for more than 5 years In this study six experts are needed to achieve a content validation index CVI satisfaction of 083 Researchers will send formal invitations via email to experts The files include an application letter a cover letter containing the research objectives expert panel criteria intervention procedures to be assessed and an assessment sheet Assessment of each item uses a 1-4 Likert scale Item with score 3 will be asked to provide comments or suggestions to help further refine the intervention protocol Researchers will use item-level CVI I-CVI and the scale-level S-CVI The CVI value is satisfactory if I-CVI 080 and S-CVI 083 Items with a low CVI value will be revised according to the comments and suggestions of experts until the CVI value becomes satisfactory
Participants Recruitment Process
Researchers will ask the District Health Service for information about public health centers PHCs with active Chronic Disease Management Program PROLANIS activities Researchers will contact and collaborate with PHCs for participant recruitment The research team will contact each potential participant and explain the research process Researchers will also put-up posters in PHCs and also distribute these posters through social media Potential participants willing to become participants can contact the contacts listed on the poster For potential respondents who are willing after signing the informed consent they will be included in the chat group Participants will be given a transportation fee of IDR 25000 for each arrival during the data collection process
Sample Size Calculation
Samples were calculated using GPower sample size calculator v31 using F test with an analysis of variance based on some criteria Researchers will use small effect size 01 an α error probability of 005 and a power of 090 Number of groups 3 foot-ankle exercise walking exercise and control group and number of measurements 3 baseline 6-weeks and 12 weeks Based on the calculation 261 participants were needed and added an anticipated dropout of 20 55 people so the total sample size was 315 The total sample was divided into three groups each group had 105 participants
Randomization and Allocation Concealment
Eligible participants will be randomized by independent staff not involved in the recruitment and data collection process with a ratio of 111 for each group After baseline measurements the randomization process will be carried out using the computer-generated randomization method The method that will be used is random permuted blocks with size 3 6 9 The random numbers will be packaged in sequence stored and locked in opaque envelopes to guarantee allocation concealment This sequence will be kept private and stored in a place that assessors cannot access
Intervention Delivery
Control group The active control group was given health education on the topic of DM for 30 minutes and then given a leaflet
Foot-ankle exercise group Participants will be given health education on DM and foot-ankle exercise after the allocation procedure followed by simulation and practice lasts 60 minutes Participants were also given leaflets and videos to take home Afterward participants will practice independently without supervision for 12 weeks Foot-ankle exercise consists of 10 movements When doing foot exercises participants sit comfortably without leaning and the soles of their feet touch the floor and barefoot These movements are
A 1Lift the soles of the feet with heels still touching the floor2Toes are bent to grip like chicken claws in this position3Repeat this movement 10x
B 1Lift the soles of the feet with heels still touching the floor 2Lower the soles of feet and raise heels with toes touching the floor 3Repeat this movement 10x
C 1Lift the soles of the feet with heels still touching the floor2Do circular movements from the inside to the outside for the soles of both feet3Repeat this movement 10x
D 1Lift the heels of both feet with toes still touching the floor2Do circular movements from the inside to the outside for the soles of both feet3Repeat this movement 10x
E 1Lift right knee and straighten it The left leg remains in its original position2Move toes forward and backward3Repeat this movement 10x4Do the same for the left leg
F 1Lift right knee and straighten it2The left leg remains in its original position3Move toes towards face4Repeat this movement 10x5Do the same for the left leg
G 1Lift both knees of the right and left legs then straighten them2Move toes towards face at the same time3Repeat this movement 10x
H 1Lift both knees of the right and left legs then straighten them2Move both legs forward3Repeat this movement 10x
I 1Lift their right knee and straighten it The left leg remains in its original position2Write the numbers 1-10 with feet3Do the same movement for the left leg
J 1Place newspapers as a base for the soles2Shape the newspaper into a ball using both feet3Open the newspaper ball again to become sheet-like before using both feet4Divide the newspaper into two parts using both feet5Tear one part of the newspaper into small pieces and collect it on top of the other part of the newspaper6The newspaper sheet containing small shreds is made into a ball using both feet7Throw the newspaper ball into the trash
Walking exercise group Participants will be given health education for 30 minutes on DM and walking exercises and leaflet after the allocation procedure Participants will practice walking exercises independently for 12 weeks
Health education for all groups is provided by persons who have certificates as DM educators and carried out in subgroups with 7-10 members in each group To avoid contamination health education was implemented at different times Fridays for control group Saturday for foot-ankle exercise group and Sunday for walking exercise group with flexible implementation hours according to the agreement of each group All group participants were included in the chat group Whatsapp Messenger so that researchers could communicate and monitor the implementation of the intervention
Interventionist dan Outcome Investigators
Each research location has 1 health professional who carries out the intervention with criteria having a masters degree in nursing working as a health workerhealth educator for at least 5 years and having a certificate as a DM educator Each research location has at least of 1 outcome investigator with the criteria of a health worker with a registration certificate
Plan for Data ManagementAnalysis
Data analysis will use the intention to treat ITT principle In addition an analysis using the per-protocol PP principle will be carried out Then Researchers will compare the analysis results using ITT and PP and conduct a sensitivity test The data analysis process uses the SPSS V27 program Researchers will conduct a normality test using the Kolmogorov Smirnov test the data distribution is normal if the value is 005 Researchers will use the Generalized Estimating Equation GEE test to analyze changes in outcomes between the foot-ankle exercise group vs control group walking exercise group vs control group and foot-ankle exercise group vs walking exercise group over time baseline six weeks and 12 weeks Baseline measurement and control group as reference The significance value uses p value 005
Comparison data of baseline respondents between the 3 groups for categorical data will be analyzed by the Chi-squareFisher Exact test for numerical data ANOVA test for normal distributed or Friedman test for non-normally distributed If a significant imbalance is found an appropriate covariance adjustment analysis will be carried out in the data analysis Analysis within group for each measurement time baseline vs six weeks baseline vs 12 weeks six weeks vs 12 weeks will use the Paired T-test if normally distributed or the Wilcoxon test if non-normally distributed Meanwhile the analysis between groups for each measurement time T0 T1 and T2 will use the Independent T-test for normally distributed or the Mann-Whitney test for non-normally distributed
Researchers will use path analysis to analyze the mediationmoderator of BMI FBG BP ABI and stress on the effects of foot-ankle exercise and walking exercise on foot sensitivity and QoL The mediation analysis will use the bootstrap technique as a nonparametric procedure to test the statistical significance of various Partial Least Squares-Structural Equation Model PLS-SEM results such as path coefficients Researchers will use the software program SmartPLS 3 SmartPLS GmbH Bonningstedt Germany to analyze the mediation effects For PLS-SEM Standard Root Mean Square ResidualSRMR can be used as a goodness-of-fit test to prevent model specification errors SRMR is the difference between the observed correlation and the models implied correlation matrix As a result it is possible to use the average magnitude of the difference between measured and predicted correlations as an absolute measure of model goodness-of-fit A good fit is described as a value smaller than 010 or 008 The statistically significant level was set at 005 and 95 confidence intervals CI to test indirect effects The result indicates a significant level if the 95 CI does not contain zero
Monitor for Adverse Events
Adverse events that have the potential to occur include fatigue muscle aches pain and dizziness Participants will record for themselves if adverse events occur and report to the team The research team also monitored by telephone once a week asking whether any adverse events had occurred and recording them If excessive adverse events occur investigators will immediately stop the intervention and carry out treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None