Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575621
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Knee-hip Surgery Wait-list Support Program
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Re-imagining Hip and Knee Arthroplasty Wait-list in Nova Scotia Pre-surgery Support Program
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:
This project will outline a pre-surgery support program that identifies risk factors related to poor surgical outcomes and recommends actions to improve these before surgery
The main questions this study attempts to answer are
1 Is a formalized knee-hip pre-surgery support program feasible measured by recruitment rate adherence and completion rate
2 Does the support program improve surgical risk factors including hemoglobin A1c HB A1C blood pressure hemoglobin estimated glomerular filtration rate eGFR frailty score and physical fitness and function measured with the 2-minute step test and 30s second sit to stand test
Participants will participate in education medical navigation and exercise
The main questions this study attempts to answer are
1 Is a formalized knee-hip pre-surgery support program feasible measured by recruitment rate adherence and completion rate
2 Does the support program improve surgical risk factors including hemoglobin A1c HB A1C blood pressure hemoglobin estimated glomerular filtration rate eGFR frailty score and physical fitness and function measured with the 2-minute step test and 30s second sit to stand test
Participants will participate in education medical navigation and exercise
Detailed Description:
Study Design
This is a non-randomized pragmatic pilot intervention study
Participants
Up to 100 people will participate in this pilot study A minimum of 30 participants is required 20 in the exercise group and 5 in each control group This would give the investigators enough data to assess the feasibility of the exercise class as well as to develop means and standard deviations SDs of change that could inform a power calculation for a controlled trial
Recruitment
Eligible participants will be identified through four Valley Regional Hospital VRH orthopedic surgeons wait-lists Staff in the surgeons offices will contact potential participants and inform them about the study If patients indicate they are interested and willing to be contacted by study staff the staff member will document this and inform the research coordinator via email NS Health email to NS Health email The research coordinator will then contact potential participants to provide more details on the study confirm eligibility and if the person is willing to participate obtain verbal consent to enroll them in the study
Procedures
After verbal consent to enroll in the study is obtained the research coordinator will schedule the participant for their baseline assessment The participant will also have the option of providing an email address to receive an electronic version of the consent form so they can review it prior to the baseline assessment At the baseline assessment the research coordinator will review the consent form with participants and they will be required to sign a paper copy of the consent form at this time in order to proceed with the assessment The research coordinator will answer any questions and address any concerns participants have regarding the study If a participant decides they no longer want to take part in the study the research coordinator will not proceed with the assessment After signing the consent form participants may withdraw at any time and will not be required to provide a reason for withdrawal
The baseline assessment will include blood pressure height weight the Oxford questionnaire Euroqol 5 dimension questionnaire 5 level version EQ-5D-5L Godin-Shepherd Leisure-Time Physical Activity Questionnaire frailty screen and questions about demographics health behaviours including smoking and drinking and medical history It will also include two fitness tests- the 2-minute step test and the 30 second sit to stand test Bloodwork for hemoglobin A1c Hb A1c estimated glomerular filtration rate eGFR and hemoglobin Hb may be done at this time at the hospital lab Although this bloodwork is normally collected at the VRH Orthopedic Assessment Clinic OAC initial assessment if there is not bloodwork available within the two months prior to study enrollment it will be requested through the OAC or by Dr Robert Doyle
At the end of the assessment the research coordinator will make any recommendations to the participant based on the program algorithm When the results of the bloodwork are available the research coordinator will follow-up with the participants via phone call with any additional recommendations Possible recommendations include joining the study exercise program receiving educational videos a consultation with a dietician receiving smoking or alcohol cessation resources and seeing their primary care physician or a specialist in the internal medicine department Any necessary referrals will be made through the OAC staff for dietician consults or Dr Robert Doyle for internal medicine consults
This process will create three study groups Participants who do not require enhanced medical support will be healthy controls due to positive health indicators These participants will still receive educational materials and any necessary referrals but do not have any flags that require referral for enhanced support The primary group of interest are the exercise group participants who have flags identified through the algorithm and are recommended the enhanced support that includes the exercise program All participants who do require the exercise program will be offered a spot however they can decline this offer and remain in the study This will create an additional third group of participants that are unhealthy controls ie those that are recommended the enhanced support but decline the exercise program Both the healthy and unhealthy control groups are valuable to include to accurately track the break-out of participants for feasibility evaluation as well as indicate the trajectories of status indicators for healthy and unhealthy participants while on the wait list for surgery If the participant is recommended to exercise and chooses to take part in the study exercise program they will undergo additional screening with the research coordinator using the Physical Activity Readiness Questionnaire PAR-Q to ensure they can safely participate Any contraindications to exercise identified during the screening process such as supplemental oxygen or resting blood pressure above 200110 will require medical clearance prior to beginning exercise
After the baseline assessment variables for timepoint 0 initial assessment at OAC will be abstracted from patients medical records These variables are routinely measured at initial assessments at the OAC Abstraction will be done by the research coordinator To ensure the correct persons information is abstracted the research coordinator will make sure the name and health care number on the record match the information provided by the participant
Participants in the exercise group will attend twice weekly hour-long sessions led by the research coordinator who is a kinesiologist Both virtual and in-person options will be available In-person classes will take place at Valley Regional Hospital and Acadia University Centre for Lifestyle studies and virtual classes will be delivered via Zoom In-person sessions will be either group personal training 3-5 participants doing their own program under the supervision of the kinesiologist or circuit classes taught by the kinesiologist Virtual sessions will be a circuit class taught by the kinesiologist All necessary precautions to ensure safety will be taken including emergency contact information For both virtual and in-person programs each session will be comprised of aerobic resistance balance and flexibility exercises Resistance exercises will target major muscle groups including quadriceps hamstrings gluteals chest back shoulders biceps and core Sessions will begin with a warm-up and will include at least one exercise targeting each of the aforementioned muscle groups Sessions will end with a balance exercise and stretches The instructor will modify any exercises or offer alternatives for individuals that need them Length of the program will vary between participants based on their surgery date They will exercise from the time they join the program until their surgery The last planned exercise session will be within one week of participants surgery It is anticipated that most participants will exercise for 8-16 weeks A minimum duration of 6 weeks of exercise is typically needed to see significant improvements in variables due to exercise
The principal investigator or research coordinator may remove participants from the exercise program if a change in their health makes the program unsafe for them Examples include a heart attack stroke or injury that substantially impacts a participants ability to exercise safely If this happens the research team will discuss with the participant whether or not they wish to remain in the study and what their options are for receiving care outside the study
All participants will undergo a second assessment approximately two weeks before surgery This assessment will occur at the same time as their anesthetic pre-op appointment in the pre-anesthesia clinic and will include blood tests the Oxford questionnaire the EQ-5D-5L Godin physical activity questionnaire 30 second sit to stand test 2-minute step test and a satisfaction survey Staff in the pre-anesthesia clinic will complete a data collection form and administer the questionnaires and fitness tests The medical variables included in this form including bloodwork are routinely measured at anesthetic pre-op appointments To assess post-op health-related quality of life and physical function participants will complete the questionnaires and the 30 second sit to stand test again at their six-week post-op appointment with their surgeon Staff in the surgeons office will complete a data collection form
Data Analysis
Data will be cleaned prior to analysis and all variables will be examined for missing responses Descriptive analyses will be performed for all variables to examine the distribution and outliers for the sample All continuous variables will be examined for normal distributions by comparing the mean SD median interquartile range IQR skewness and examining histograms For categorical variables frequencies and percentages will be examined
To evaluate feasibility recruitment rate mean attendance to the exercise program and completion rate will be calculated and reported Post-op morbidity and death or serious morbidity rates and results from the satisfaction survey will also be reported For all other outcomes means SDs and 95 confidence intervals for normally distributed data and medians and IQR for non-normally distributed data will be reported Effect sizes will be reported to inform the sample size for a future definitive trial Program satisfaction will be assessed at follow-up using the satisfaction survey as well as semi-structured interviews with open-ended questions to understand the positive and negative aspects of each program from participants The semi-structured interviews will be optional These data will be analyzed in collaboration with a social scientist
To evaluate change in risk factors the investigators will report mean change in the questionnaires functional and medicalsurgical outcomes Mean change will be compared to minimally clinically important differences MCIDs for all outcomes which have an established MCID in hip and knee osteoarthritis patients For outcomes which do not have an established MCID the investigators will report the number and percentage of participants in the green yellow and red categories at the OAC initial assessment study baseline and pre-surgery as well as the number and percentage of participants who move from one category to another across these three timepoints
This is a non-randomized pragmatic pilot intervention study
Participants
Up to 100 people will participate in this pilot study A minimum of 30 participants is required 20 in the exercise group and 5 in each control group This would give the investigators enough data to assess the feasibility of the exercise class as well as to develop means and standard deviations SDs of change that could inform a power calculation for a controlled trial
Recruitment
Eligible participants will be identified through four Valley Regional Hospital VRH orthopedic surgeons wait-lists Staff in the surgeons offices will contact potential participants and inform them about the study If patients indicate they are interested and willing to be contacted by study staff the staff member will document this and inform the research coordinator via email NS Health email to NS Health email The research coordinator will then contact potential participants to provide more details on the study confirm eligibility and if the person is willing to participate obtain verbal consent to enroll them in the study
Procedures
After verbal consent to enroll in the study is obtained the research coordinator will schedule the participant for their baseline assessment The participant will also have the option of providing an email address to receive an electronic version of the consent form so they can review it prior to the baseline assessment At the baseline assessment the research coordinator will review the consent form with participants and they will be required to sign a paper copy of the consent form at this time in order to proceed with the assessment The research coordinator will answer any questions and address any concerns participants have regarding the study If a participant decides they no longer want to take part in the study the research coordinator will not proceed with the assessment After signing the consent form participants may withdraw at any time and will not be required to provide a reason for withdrawal
The baseline assessment will include blood pressure height weight the Oxford questionnaire Euroqol 5 dimension questionnaire 5 level version EQ-5D-5L Godin-Shepherd Leisure-Time Physical Activity Questionnaire frailty screen and questions about demographics health behaviours including smoking and drinking and medical history It will also include two fitness tests- the 2-minute step test and the 30 second sit to stand test Bloodwork for hemoglobin A1c Hb A1c estimated glomerular filtration rate eGFR and hemoglobin Hb may be done at this time at the hospital lab Although this bloodwork is normally collected at the VRH Orthopedic Assessment Clinic OAC initial assessment if there is not bloodwork available within the two months prior to study enrollment it will be requested through the OAC or by Dr Robert Doyle
At the end of the assessment the research coordinator will make any recommendations to the participant based on the program algorithm When the results of the bloodwork are available the research coordinator will follow-up with the participants via phone call with any additional recommendations Possible recommendations include joining the study exercise program receiving educational videos a consultation with a dietician receiving smoking or alcohol cessation resources and seeing their primary care physician or a specialist in the internal medicine department Any necessary referrals will be made through the OAC staff for dietician consults or Dr Robert Doyle for internal medicine consults
This process will create three study groups Participants who do not require enhanced medical support will be healthy controls due to positive health indicators These participants will still receive educational materials and any necessary referrals but do not have any flags that require referral for enhanced support The primary group of interest are the exercise group participants who have flags identified through the algorithm and are recommended the enhanced support that includes the exercise program All participants who do require the exercise program will be offered a spot however they can decline this offer and remain in the study This will create an additional third group of participants that are unhealthy controls ie those that are recommended the enhanced support but decline the exercise program Both the healthy and unhealthy control groups are valuable to include to accurately track the break-out of participants for feasibility evaluation as well as indicate the trajectories of status indicators for healthy and unhealthy participants while on the wait list for surgery If the participant is recommended to exercise and chooses to take part in the study exercise program they will undergo additional screening with the research coordinator using the Physical Activity Readiness Questionnaire PAR-Q to ensure they can safely participate Any contraindications to exercise identified during the screening process such as supplemental oxygen or resting blood pressure above 200110 will require medical clearance prior to beginning exercise
After the baseline assessment variables for timepoint 0 initial assessment at OAC will be abstracted from patients medical records These variables are routinely measured at initial assessments at the OAC Abstraction will be done by the research coordinator To ensure the correct persons information is abstracted the research coordinator will make sure the name and health care number on the record match the information provided by the participant
Participants in the exercise group will attend twice weekly hour-long sessions led by the research coordinator who is a kinesiologist Both virtual and in-person options will be available In-person classes will take place at Valley Regional Hospital and Acadia University Centre for Lifestyle studies and virtual classes will be delivered via Zoom In-person sessions will be either group personal training 3-5 participants doing their own program under the supervision of the kinesiologist or circuit classes taught by the kinesiologist Virtual sessions will be a circuit class taught by the kinesiologist All necessary precautions to ensure safety will be taken including emergency contact information For both virtual and in-person programs each session will be comprised of aerobic resistance balance and flexibility exercises Resistance exercises will target major muscle groups including quadriceps hamstrings gluteals chest back shoulders biceps and core Sessions will begin with a warm-up and will include at least one exercise targeting each of the aforementioned muscle groups Sessions will end with a balance exercise and stretches The instructor will modify any exercises or offer alternatives for individuals that need them Length of the program will vary between participants based on their surgery date They will exercise from the time they join the program until their surgery The last planned exercise session will be within one week of participants surgery It is anticipated that most participants will exercise for 8-16 weeks A minimum duration of 6 weeks of exercise is typically needed to see significant improvements in variables due to exercise
The principal investigator or research coordinator may remove participants from the exercise program if a change in their health makes the program unsafe for them Examples include a heart attack stroke or injury that substantially impacts a participants ability to exercise safely If this happens the research team will discuss with the participant whether or not they wish to remain in the study and what their options are for receiving care outside the study
All participants will undergo a second assessment approximately two weeks before surgery This assessment will occur at the same time as their anesthetic pre-op appointment in the pre-anesthesia clinic and will include blood tests the Oxford questionnaire the EQ-5D-5L Godin physical activity questionnaire 30 second sit to stand test 2-minute step test and a satisfaction survey Staff in the pre-anesthesia clinic will complete a data collection form and administer the questionnaires and fitness tests The medical variables included in this form including bloodwork are routinely measured at anesthetic pre-op appointments To assess post-op health-related quality of life and physical function participants will complete the questionnaires and the 30 second sit to stand test again at their six-week post-op appointment with their surgeon Staff in the surgeons office will complete a data collection form
Data Analysis
Data will be cleaned prior to analysis and all variables will be examined for missing responses Descriptive analyses will be performed for all variables to examine the distribution and outliers for the sample All continuous variables will be examined for normal distributions by comparing the mean SD median interquartile range IQR skewness and examining histograms For categorical variables frequencies and percentages will be examined
To evaluate feasibility recruitment rate mean attendance to the exercise program and completion rate will be calculated and reported Post-op morbidity and death or serious morbidity rates and results from the satisfaction survey will also be reported For all other outcomes means SDs and 95 confidence intervals for normally distributed data and medians and IQR for non-normally distributed data will be reported Effect sizes will be reported to inform the sample size for a future definitive trial Program satisfaction will be assessed at follow-up using the satisfaction survey as well as semi-structured interviews with open-ended questions to understand the positive and negative aspects of each program from participants The semi-structured interviews will be optional These data will be analyzed in collaboration with a social scientist
To evaluate change in risk factors the investigators will report mean change in the questionnaires functional and medicalsurgical outcomes Mean change will be compared to minimally clinically important differences MCIDs for all outcomes which have an established MCID in hip and knee osteoarthritis patients For outcomes which do not have an established MCID the investigators will report the number and percentage of participants in the green yellow and red categories at the OAC initial assessment study baseline and pre-surgery as well as the number and percentage of participants who move from one category to another across these three timepoints
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