Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574854
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Effects of Descending Stair Walking
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Descending Stair Walking on Cardiometabolic Adaptations Among Obese Untrained Women
Status:
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:
DSW
Brief Summary:
The global rise in the prevalence of physical inactivity is major public health concern Lifestyle-related activities such as stairs walking has important public health implications and may represent an alternative approach for those who have difficulty adhering to conventional exercise programs This two-armed parallel-group randomized controlled trial RCT aims to assess and compare the effects between the descending stair walking DSW and ascending stair walking ASW on cardiometabolic health markers cardiopulmonary capacity body composition and muscular strength
This RCT will recruit 16 obese inactive and sedentary females will be randomized using permuted block randomization into two arms intervention arm DSW and active comparator arm ASW in a 11 allocation ratio The participants in the DSW and ASW arms will undergo twice a week stair walking intervention session for 8 weeks The exercise volume will be gradually increased over 8 weeks by increasing the number of repetitions by two every week for both arms Borgs scale of perceived exertion RPE and visual analogue scale VAS will be used to assess subjective intensity of stair walking and pain intensity immediately after each repetition Assessments will be carried out through two time points pre-intervention assessment T0 and immediately after completion of the intervention at 8 weeks T1 During each assessment the primary outcome to be assessed includes the cardiometabolic health markers and cardiopulmonary capacity while the secondary outcomes to be assessed are the body composition and muscular strength Whereas during the intervention continuous heart rate and gas consumption will be monitored at week 1 W1 week 4 W4 and week 8 W8 to monitor the intensity of the exercise
This RCT will recruit 16 obese inactive and sedentary females will be randomized using permuted block randomization into two arms intervention arm DSW and active comparator arm ASW in a 11 allocation ratio The participants in the DSW and ASW arms will undergo twice a week stair walking intervention session for 8 weeks The exercise volume will be gradually increased over 8 weeks by increasing the number of repetitions by two every week for both arms Borgs scale of perceived exertion RPE and visual analogue scale VAS will be used to assess subjective intensity of stair walking and pain intensity immediately after each repetition Assessments will be carried out through two time points pre-intervention assessment T0 and immediately after completion of the intervention at 8 weeks T1 During each assessment the primary outcome to be assessed includes the cardiometabolic health markers and cardiopulmonary capacity while the secondary outcomes to be assessed are the body composition and muscular strength Whereas during the intervention continuous heart rate and gas consumption will be monitored at week 1 W1 week 4 W4 and week 8 W8 to monitor the intensity of the exercise
Detailed Description:
12 Research Objectives
121 General Objective i The study compares the impact of the 8-week descending stair walking DSW and ascending stair walking ASW on cardiometabolic health in obese untrained women
122 Specific Objective
To compare the effect of DSW ASW on
i cardiometabolic health fasting plasma glucose lipid profile renal profile cardiorespiratory fitness resting blood pressure resting energy expenditure resting heart rate ii body composition fat mass lean body mass waist circumference hip circumference thigh circumference iii muscular fitness functional capacity back and leg strength 6-min walking test
13 Research Design This randomized controlled trial RCT is a single-centre two-armed parallel-group
14 Research Location This RCT is expected to run for 1 year in the Wellness Hub Timur Laut Klinik Kesihatan Jalan Angsana Pulau Pinang Wellness Hub Timur Laut is located in the primary healthcare facility of the Ministry of Health and receives approximately 1000 clients annually for health screening
15 Sampling Method The sampling method used in this study for recruitment of participants is by purposive sampling Overweight obese clients of Wellness Hub Jalan Angsana Klinik Kesihatan Jalan Angsana Pulau Pinang
16 Sample Size Calculation The sample size is estimated based on an effect size of 191 an α-level of 005 and a power 1-β of 008 A priori sample size analysis GPower 31 Düsseldorf Germany indicated that 6 participants group were necessary Considering a possible dropout rate of 50 a sample size of 12 participants group is anticipated making it a total of 24 participants
17 Data Collection Procedure Permission to conduct the study in Wellness Hub Timur Laut WHTL Pulau Pinang will be sought Clients will be recruited from WHLA after agreeing to participate in the study
171 Data Collection Technique The researcher will interview and assess participants face-to-face at baseline and 8th weeks and the end of the intervention Participants will be randomly assigned to the stair-walking intervention At baseline a background information questionnaire will be used to obtain respondents sociodemographic characteristics occupation health problems and health-related fitness as part of wellness hub health screening Body composition metabolic risk factors and selected physical fitness will be assessed before and after the 8th week of intervention
172 Daily Energy Balance Monitoring A logbook will be provided for all participants to record daily calorie intake and physical activity Two weekdays and one-weekend food logs will be retrieved from the logbook and the total weekly calorie intake and macronutrients will be calculated using Nutritionist Pro software
173 Stair Walking Intervention All participants must complete progressive exercise training using stairs in WHLA over 8 weeks twice a week The participants in the DSW arm will ride an elevator from level 1 to level 6 eliminating the concentric impact of walking upstairs Whereas for the ASW arm participants will ride an elevator from level 6 to level 1 to eliminate the eccentric impact of walking downstairs The number of stairs from the first to the sixth floor was 120 five floors 24 stairs per floor and the height of each stair was 18 cm The walking tempo is approximately 1s per step thus to descend or ascend 120 stairs it takes about 2 min 30 sec including steps at the landing The exercise volume will be gradually increased over 8 weeks by increasing the number of repetitions by two repetitions weekly for both arms first week 2 repetitions session 8th week 16 repetitions session 1 repetition120 stairs
This protocol assumes that symptoms of muscle damage such as delayed-onset muscle soreness DOMS and prolonged decreases in muscle function would be minimal after any sessions It took approximately 5 min to perform one repetition including the time used for waiting for and riding on an elevator and the time taken to perform 16 repetitions was approximately 80 min Lower limb stretching exercises will be included in the workouts general warming-up and cooling-down phases Over the 16 sessions each participant will walk up or down 720 floors thus 17424 stairs
121 General Objective i The study compares the impact of the 8-week descending stair walking DSW and ascending stair walking ASW on cardiometabolic health in obese untrained women
122 Specific Objective
To compare the effect of DSW ASW on
i cardiometabolic health fasting plasma glucose lipid profile renal profile cardiorespiratory fitness resting blood pressure resting energy expenditure resting heart rate ii body composition fat mass lean body mass waist circumference hip circumference thigh circumference iii muscular fitness functional capacity back and leg strength 6-min walking test
13 Research Design This randomized controlled trial RCT is a single-centre two-armed parallel-group
14 Research Location This RCT is expected to run for 1 year in the Wellness Hub Timur Laut Klinik Kesihatan Jalan Angsana Pulau Pinang Wellness Hub Timur Laut is located in the primary healthcare facility of the Ministry of Health and receives approximately 1000 clients annually for health screening
15 Sampling Method The sampling method used in this study for recruitment of participants is by purposive sampling Overweight obese clients of Wellness Hub Jalan Angsana Klinik Kesihatan Jalan Angsana Pulau Pinang
16 Sample Size Calculation The sample size is estimated based on an effect size of 191 an α-level of 005 and a power 1-β of 008 A priori sample size analysis GPower 31 Düsseldorf Germany indicated that 6 participants group were necessary Considering a possible dropout rate of 50 a sample size of 12 participants group is anticipated making it a total of 24 participants
17 Data Collection Procedure Permission to conduct the study in Wellness Hub Timur Laut WHTL Pulau Pinang will be sought Clients will be recruited from WHLA after agreeing to participate in the study
171 Data Collection Technique The researcher will interview and assess participants face-to-face at baseline and 8th weeks and the end of the intervention Participants will be randomly assigned to the stair-walking intervention At baseline a background information questionnaire will be used to obtain respondents sociodemographic characteristics occupation health problems and health-related fitness as part of wellness hub health screening Body composition metabolic risk factors and selected physical fitness will be assessed before and after the 8th week of intervention
172 Daily Energy Balance Monitoring A logbook will be provided for all participants to record daily calorie intake and physical activity Two weekdays and one-weekend food logs will be retrieved from the logbook and the total weekly calorie intake and macronutrients will be calculated using Nutritionist Pro software
173 Stair Walking Intervention All participants must complete progressive exercise training using stairs in WHLA over 8 weeks twice a week The participants in the DSW arm will ride an elevator from level 1 to level 6 eliminating the concentric impact of walking upstairs Whereas for the ASW arm participants will ride an elevator from level 6 to level 1 to eliminate the eccentric impact of walking downstairs The number of stairs from the first to the sixth floor was 120 five floors 24 stairs per floor and the height of each stair was 18 cm The walking tempo is approximately 1s per step thus to descend or ascend 120 stairs it takes about 2 min 30 sec including steps at the landing The exercise volume will be gradually increased over 8 weeks by increasing the number of repetitions by two repetitions weekly for both arms first week 2 repetitions session 8th week 16 repetitions session 1 repetition120 stairs
This protocol assumes that symptoms of muscle damage such as delayed-onset muscle soreness DOMS and prolonged decreases in muscle function would be minimal after any sessions It took approximately 5 min to perform one repetition including the time used for waiting for and riding on an elevator and the time taken to perform 16 repetitions was approximately 80 min Lower limb stretching exercises will be included in the workouts general warming-up and cooling-down phases Over the 16 sessions each participant will walk up or down 720 floors thus 17424 stairs
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