Health Behavior Clinical Trial
Official title:
A Comparison Between Two Repetition Prescription Approaches in Resistance Training Delivered Via Videoconferencing to Untrained Young Adults
NCT number | NCT04895865 |
Other study ID # | IHalperin |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 23, 2021 |
Est. completion date | August 10, 2021 |
Verified date | August 2021 |
Source | Tel Aviv University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized controlled trial comparing between two approaches of prescribing repetition-numbers in resistance training (RT) sessions on psychological, physiological, and performance outcomes. Sixty healthy and sedentary adults (age range: 18-45) will be randomly allocated to either the "predetermined" or "self-selected" groups. The groups will differ in the amount of choice they will be able to make concerning the resistance of each exercise and the number of repetitions they complete (see detailed description). Both groups will complete two sessions per week composed of body weight and resistance band exercises, lasting 45 minutes for eight weeks. The sessions will be delivered live by a certified instructor using a videoconferencing platform. The primary aim of this study is: Compare between the "predetermined" and the "self-selected" repetition prescription approaches on psychological, physiological, and performance outcomes in a cohort of 60 healthy and sedentary adults (age range: 18-45) over an eight-week period of live, videoconferencing RT sessions. The secondary aim is: Determine the influence of live, videoconferencing group RT sessions on psychological, physiological, and performance outcomes across groups.
Status | Completed |
Enrollment | 58 |
Est. completion date | August 10, 2021 |
Est. primary completion date | August 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Healthy - Non-active (characterized by 60 minutes or less per week of formal exercise sessions) - Ages of 18-45 - Did not participate in RT in the past six months. - Participants will be asked to fill out a health questionnaire. If they marked any of the items on the health questionnaire as positive (e.g., diabetes) they were asked to provide a medical clearance from a doctor. - Signing a health declaration to participate in physical activity according to the government regulations Exclusion Criteria: - Orthopedic or neurological conditions - Diagnosis of co-morbidities - Routine use of prescription medication - Pregnancy - Less than six months after childbirth |
Country | Name | City | State |
---|---|---|---|
Israel | Tel Aviv University | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel Aviv University | Israel Science Foundation |
Israel,
Emanuel A, Har-Nir I, Rozen Smukas II, Halperin I. The effect of self-selecting the number of repetitions on motor performance and psychological outcomes. Psychol Res. 2021 Sep;85(6):2398-2407. doi: 10.1007/s00426-020-01402-4. Epub 2020 Aug 10. — View Citation
Lopes JSS, Machado AF, Micheletti JK, de Almeida AC, Cavina AP, Pastre CM. Effects of training with elastic resistance versus conventional resistance on muscular strength: A systematic review and meta-analysis. SAGE Open Med. 2019 Feb 19;7:2050312119831116. doi: 10.1177/2050312119831116. eCollection 2019. Review. Erratum in: SAGE Open Med. 2020 Sep 9;8:2050312120961220. — View Citation
Patall EA, Cooper H, Robinson JC. The effects of choice on intrinsic motivation and related outcomes: a meta-analysis of research findings. Psychol Bull. 2008 Mar;134(2):270-300. doi: 10.1037/0033-2909.134.2.270. — View Citation
Schwartz H, Har-Nir I, Wenhoda T, Halperin I. Staying physically active during the COVID-19 quarantine: exploring the feasibility of live, online, group training sessions among older adults. Transl Behav Med. 2021 Mar 16;11(2):314-322. doi: 10.1093/tbm/ibaa141. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline enjoyment score | Participants will respond to a bi-monthly survey introducing the question: "how much did you enjoy the previous four sessions?" using a visual analog scale (VAS) ranging from (-100) (i.e., did not enjoy it at all) to 100 (i.e., enjoyed it very much). First, the change in scores from one time point the previous one will be calculated, resulting in three change scores across the duration of the study (e.g., week 4 minus week 2, week 6 minus week 4, etc.). Then, the three change scores will be averaged per group and compared between groups as the main outcome. | Change from week two to week four, week six and the end of the program on week eight. | |
Secondary | Adherence proportion | The proportion of adherence to the program calculated as session attended divided by the total sessions, times 100 over a period of eight weeks. | Through study completion, a period of eight weeks. | |
Secondary | Change in fat free mass (FFM) | SECA mBCA 515 device (MFBIA; SECA®, Hamburg, Germany) will be used to measure bioimpedance. Participants will be asked to drink 400 ml of water on the day of measurement and up to 30 minutes before stepping on the feet-electrodes bare feet. Participants will hold the hand-electrodes and the flow of low alternating current will produce an output of FFM reported in units of kilograms. | Change from baseline to the end of intervention at eight weeks. | |
Secondary | Change in body mass index (BMI) | SECA mBCA 515 device (MFBIA; SECA®, Hamburg, Germany) will be used to measure body weight and height, which will be used to calculate BMI. Participants will be asked to stand on a stadiometer to measure their height, then step on the device which will measure their weight and produce an automated output of BMI score. The change in BMI from baseline to the end of the intervention will be used as a secondary outcome. | Change from baseline to the end of intervention at eight weeks. | |
Secondary | Change in maximal strength: | The isometric mid-thigh pull (IMTP) assesses maximal strength of the body's large muscle groups. Participants will pull a fixed bar while standing on force plates (Kinvent, Deltas force plates). The force plate will measure the mean force of the three-second test. Test units are kilograms. | Change from baseline to the end of intervention at eight weeks. | |
Secondary | Change in hand-grip strength: | The hand grip test assesses maximum strength of the grip muscles through squeeze the dynamometer (Kinvent, Grip dynamometer). Measurement units are kilogram, and the peak value will be used to calculate the change from baseline. | Change from baseline to the end of intervention at eight weeks. | |
Secondary | Change in knee-extensor strength: | The isometric knee extension test will measure force by a dynamometer device attached to a firm belt (Kinvent, Link pull dynamometer). Measurement units are kilogram, and the mean force will be used for analysis. | Change from baseline to the end of intervention at eight weeks. | |
Secondary | Change in lower-body explosive power: | The counter movement jump test assesses lower body explosive power using a force plate (Kinvent, Deltas force plates). Participants will stand on the force plate with their hands on their waist and jump as high as possible. The measurement unit is centimeter, and the peak value will be used for analysis. | Change from baseline to the end of intervention at eight weeks. | |
Secondary | Change in upper body endurance: | The push-up test assesses muscular endurance of the upper body muscle groups. Participants will perform the maximal number of push-ups with their body straight and their chest touching a target. Participants will use an inclination if they cannot complete five repetitions before beginning the test. Inclination height will be recorded. The number of repetitions will be used for analysis. | Change from baseline to the end of intervention at eight weeks. | |
Secondary | Change in perception of autonomy: | Participants will be presented with three questions concerning their perceived autonomy. Participants will be asked to rate their response on a Visual Analog Scale (VAS) ranging from (-100) (i.e., not autonomous at all) to 100 (extremely autonomous). First, the change in scores from one time point the previous one will be calculated, resulting in three change scores across the duration of the study (e.g., week 4 minus week 2, week 6 minus week 4, etc.). Then, the three change scores will be averaged per group and compared between groups as a secondary outcome. | Change from week two to week four, week six and the end of the program on week eight. | |
Secondary | Change in satisfaction with the program: | Participants will be presented with three questions concerning their satisfaction with the variety of exercises, the instructor and the resistance band. Participants will be asked to rate their response on a Visual Analog Scale (VAS) ranging from (-100) (i.e., not satisfied at all) to 100 (i.e, extremely satisfied). First, the change in scores from one time point the previous one will be calculated, resulting in three change scores across the duration of the study (e.g., week 4 minus week 2, week 6 minus week 4, etc.). Then, the three change scores will be averaged per group and compared between groups as a secondary outcome. | Change from week two to week four, week six and the end of the program on week eight. | |
Secondary | Change in response to the ease of use of the rating of perceived exertion (RPE) scale: | Participants will be presented with two questions concerning the use of the RPE scale during the sessions. Participants will be asked to rate their response on a Visual Analog Scale (VAS) ranging from (-100) (not easy to use) to 100 (very easy to use). The average score of the three items will be used for analysis. | Change from week two to week four, week six and the end of the program on week eight. | |
Secondary | Change in the satisfaction with technology: | Participants will be presented with two questions concerning the use of technology (videoconferencing interface) during the sessions. Participants will be asked to rate their response on a Visual Analog Scale (VAS) ranging from (-100) (i.e., not satisfied at all) to 100 (i.e., extremely satisfied). First, the change in scores from one time point the previous one will be calculated, resulting in three change scores across the duration of the study (e.g., week 4 minus week 2, week 6 minus week 4, etc.). Then, the three change scores will be averaged per group and compared between groups as a secondary outcome. | Change from week two to week four, week six and the end of the program on week eight. | |
Secondary | Change in Basic Regulation to Exercise Questionnaire (BREQ-3) score: | Participants will respond to a 24-items questionnaire. Items are designed to explore the underlying motives to engaging in physical activity. The Likert-based items range from 0 (i.e., not true for me) to 4 (i.e., very true for me). The total score of the questionnaire will be calculated for the baseline response at the beginning of the intervention and the final response at the end of the intervention, and compared between the two groups. The absolute change in scores will be used as a secondary outcome. | Change from baseline to the end of the intervention (up to seven days from the end of week eight). |
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