- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05371587
The Effects of Autonomy and Perceptions on Resistance Training Outcomes
The Effects of the Autonomy and Perceptions Approach to Resistance Training (APART) on Body Composition, Physiological and Performance Outcomes in Healthy Young Adults: a Non-inferiority Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tel Aviv, Israel, 4059100
- Tel Aviv University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- No health issues preventing resistance training
- Body mass index (BMI) between 18.5 ("normal") and 29.9 ("overweight")
- Body weight > 50 Kg
- Without RT experience or with little experience (i.e. less than once a week in the past 12 months).
Exclusion Criteria:
- Participants who responded positively to any of the health sections and did not provide medical clearance
- Pregnant women or less than six months after childbirth
- BMI values outside of the specified range
- Body weight < 50 Kg
- RT experience exceeding the specified cut-off (see above)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: A - Standard resistance training prescription
Standard resistance training prescription: participants will perform three sessions per week comprised of six resistance training exercises - horizontal leg press, lat-pulldown, knee extension, chest press, leg curls and shoulder press. They will perform 3 sets of 10 repetitions using 65% percent of the maximal load that can be lifted once according to a one repetition maximum (1RM) test. Their progression model will be as follows: Weeks 1-3 65%1RM; Weeks 4-6 70%1RM; 1RM reassessment at week 6; Weeks 7-9 70% of the updated 1RM; Weeks 10-12 75%1RM. Prior to beginning of the program four visits will take place:
|
Standard resistance training prescription, based on international organization's guidelines.
|
|
Experimental: B- Autonomy and perceptions approach to resistance training (APART)
Participants will perform 3 sessions/week of the same exercises. They will perform 3 sets of each exercise, self-select the load they lift in each set and perform repetitions aiming to reach a level of effort of 7-8 on a 0-10 rating of perceived effort scale (RPE) at the end of the set. Their progression model will be as follows: Weeks 1-3 RPE 7/10; Weeks 4-12 RPE 8/10. The selected RPE score of 7 and then 8 out of 10 has been shown to lead to increases in maximal strength in previous research. Prior to beginning of the program four visits will take place:
|
Alternative resistance training prescription based on trainees' autonomy and perceptions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in systolic blood pressure
Time Frame: Baseline to twelve weeks
|
Participants will rest in a relaxed seating position for five minutes.
Then their blood pressure and resting heart rate will be taken using an Omron M7 (HEM-780-E) blood pressure measuring device.
|
Baseline to twelve weeks
|
|
Change in Low Density Lipoprotein (LDL) value
Time Frame: Baseline to twelve weeks
|
The blood samples will be collected by single-use disposable needle.
A total of 20 mL of blood will be collected at each time-point in two, 10 mL Vacutainer® tubes: a plasma tube containing anticoagulant and a serum tube where the blood is allowed to clot.
Plasma samples will be stored in ice until centrifuged twice at 1,500g for 10 minutes at 4° Celsius.
Serum will be kept in room temperature for 60 minutes then centrifuged at 1300g for 10 minutes.
Both samples will be divided into separate 1.8-mL microcentrifuge tubes and will be frozen at -80° C for later analysis.
|
Baseline to twelve weeks
|
|
Change in fasting glucose value
Time Frame: Baseline to twelve weeks
|
The blood samples will be collected by single-use disposable needle.
A total of 20 mL of blood will be collected at each time-point in two, 10 mL Vacutainer® tubes: a plasma tube containing anticoagulant and a serum tube where the blood is allowed to clot.
Plasma samples will be stored in ice until centrifuged twice at 1,500g for 10 minutes at 4° Celsius.
Serum will be kept in room temperature for 60 minutes then centrifuged at 1300g for 10 minutes.
Both samples will be divided into separate 1.8-mL microcentrifuge tubes and will be frozen at -80° C for later analysis
|
Baseline to twelve weeks
|
|
Change in fat free mass
Time Frame: Baseline to twelve weeks
|
Fat free mass will be measured using the SECA mBCA 515 (Seca, Hamburg, Germany), a valid and reliable analyzer of body composition.
Participants will drink 400 ml of water before the examination which will take place in the morning.
Drinking will be stopped 30 minutes before the examination and participants will be instructed to urinate and remove any jewelries before the examination.
|
Baseline to twelve weeks
|
|
Change in waist circumference
Time Frame: Baseline to twelve weeks
|
Waist circumference will be measured according to WHO protocol: Participants will expose the area between their ribs and pelvic.
The same investigator will measure the distance between the lower end of their ribcage and the anterior superior iliac spine (ASIS) and measure the waist circumference three times, midway between the two anatomical landmarks.
The average value of the three measurements in centimeters will be documented for analysis.
|
Baseline to twelve weeks
|
|
Change in maximal muscle strength- One repetition maximum
Time Frame: Baseline to twelve weeks
|
Participants will perform a dynamic warmup including mobility and calisthenics exercises, followed by specific warm up sets of each of the exercises: Horizontal leg press, knee extension and seated chest press (performed on weight-stack machines).
Then, up to five attempts will be made to complete one repetition sets with increasing load until the participant either fails to complete the full range of motion or declares she cannot attempt the next set.
The load (in kg) of the final successful attempt for each exercise will be documented for analysis.
Two to three minutes rest will be provided between the attempts.
The order of the exercises will be maintained throughout the assessment points and between participants.
The assessments will be carried out by the same experimenter at the same time of day ±2 hours.
|
Baseline to twelve weeks
|
|
Change in muscle endurance
Time Frame: Baseline to twelve weeks
|
Participants will perform a dynamic warmup including mobility and calisthenics exercises, followed by specific warm up sets of the knee extension and the chest press exercises.
Then, 70% of the participant's identified maximal load (1RM) will be used to perform repetitions until task-failure (i.e., not able to complete another repetition).
The number of completed repetitions will be documented for analysis.
The same reference load will be used at six weeks.
The order of the exercises will be maintained throughout the assessment points and between participants.
The assessments will be carried out by the same experimenter at the same time of day ±2 hours.
|
Baseline to twelve weeks
|
|
Change in maximum voluntary contraction (MVC) - knee extension
Time Frame: Baseline to twelve weeks
|
Isometric knee extension (using the knee extension machine) - will be assessed in a 90° angle using a link device (Kinvent, Link pull dynamometer) attached to a ratchet belt.
|
Baseline to twelve weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: End of week 12
|
Number of entries to the gym, documented by the gym front desk
|
End of week 12
|
|
Change in self efficacy questionnaire score
Time Frame: Baseline to twelve weeks
|
The self-efficacy questionnaire is an eight items questionnaire.
Respondents are required to read the statements and rate their level of agreement with each statement on a three points Likert scale.
Score-range is 8-24.
Higher scores indicate higher levels of self-efficacy.
|
Baseline to twelve weeks
|
|
Enjoyment
Time Frame: Six weeks to twelve weeks
|
Participants will respond to an online survey examining their levels of enjoyment from the training sessions via a bi-polar scale ranging from -50 ("did not enjoy at all") to 50 ("extremely enjoyed").
|
Six weeks to twelve weeks
|
|
Adherence without incentive
Time Frame: From week 12 to week 24
|
Number of entries to the gym, documented by the gym front desk
|
From week 12 to week 24
|
|
Change in total cholesterol value
Time Frame: Baseline to twelve weeks
|
The blood samples will be collected by single-use disposable needle.
A total of 20 mL of blood will be collected at each time-point in two, 10 mL Vacutainer® tubes: a plasma tube containing anticoagulant and a serum tube where the blood is allowed to clot.
Plasma samples will be stored in ice until centrifuged twice at 1,500g for 10 minutes at 4° Celsius.
Serum will be kept in room temperature for 60 minutes then centrifuged at 1300g for 10 minutes.
Both samples will be divided into separate 1.8-mL microcentrifuge tubes and will be frozen at -80° C for later analysis
|
Baseline to twelve weeks
|
|
Change in maximum voluntary contraction (MVC) - horizontal row
Time Frame: Baseline to twelve weeks
|
Horizontal row (using the T-bar machine) - will be assessed in a 60° elbow angle using a link device (Kinvent, Link pull dynamometer) attached to a ratchet belt.
Participants will lean their chest against the padded cushion with their feet stable on a designated built-in platform.
They will pull the T-bar arm using a narrow grip.
Their elbow angle will be measured using a goniometer.
Then, three attempts will be made using 40%, 70% and 90% of their estimated MVC, followed by three attempts of 100% (i.e., MVC).
60 seconds rest will be provided between attempts.
The average of the two high results will be documented for analysis.
|
Baseline to twelve weeks
|
|
Change in Hemoglobin
Time Frame: Baseline to twelve weeks
|
The blood samples will be collected by single-use disposable needle.
A total of 20 mL of blood will be collected at each time-point in two, 10 mL Vacutainer® tubes: a plasma tube containing anticoagulant and a serum tube where the blood is allowed to clot.
Plasma tubes will be stored in ice and a complete blood count will be done within 60 minutes via Yumizen H500 analyzer.
|
Baseline to twelve weeks
|
|
Change in maximum voluntary contraction (MVC) - horizontal row
Time Frame: Baseline to twelve weeks
|
Isometric horizontal row will be assessed in a 60° elbow flexion angle on the T-bar machine (Nautilus, WA, USA).
The same link device will be secured using ratchet belts to match the desired setup for each participant.
|
Baseline to twelve weeks
|
|
Change in High Density Lipoprotein (HDL) value
Time Frame: Baseline to twelve weeks
|
The blood samples will be collected by single-use disposable needle.
A total of 20 mL of blood will be collected at each time-point in two, 10 mL Vacutainer® tubes: a plasma tube containing anticoagulant and a serum tube where the blood is allowed to clot.
Plasma samples will be stored in ice until centrifuged twice at 1,500g for 10 minutes at 4° Celsius.
Serum will be kept in room temperature for 60 minutes then centrifuged at 1300g for 10 minutes.
Both samples will be divided into separate 1.8-mL microcentrifuge tubes and will be frozen at -80° C for later analysis.
|
Baseline to twelve weeks
|
|
Change in triglycerides value
Time Frame: Baseline to twelve weeks
|
The blood samples will be collected by single-use disposable needle.
A total of 20 mL of blood will be collected at each time-point in two, 10 mL Vacutainer® tubes: a plasma tube containing anticoagulant and a serum tube where the blood is allowed to clot.
Plasma samples will be stored in ice until centrifuged twice at 1,500g for 10 minutes at 4° Celsius.
Serum will be kept in room temperature for 60 minutes then centrifuged at 1300g for 10 minutes.
Both samples will be divided into separate 1.8-mL microcentrifuge tubes and will be frozen at -80° C for later analysis.
|
Baseline to twelve weeks
|
|
Change in stroke volume
Time Frame: Baseline to twelve weeks
|
Participants will wear an FDA approved wristwatch (Biobeat technologies, Petah Tikva, Israel) while resting in a seated position.
Measurements will be taken in an urgent mode - every minute for five minutes.
|
Baseline to twelve weeks
|
|
Change in fat percentage
Time Frame: Baseline to twelve weeks
|
Fat percent will be measured using the SECA mBCA 515 (Seca, Hamburg, Germany), a valid and reliable analyzer of body composition.
Participants will drink 400 ml of water before the examination which will take place in the morning.
Drinking will be stopped 30 minutes before the examination and participants will be instructed to urinate and remove any jewelries before the examination.
|
Baseline to twelve weeks
|
|
Change in body mass index (BMI)
Time Frame: Baseline to twelve weeks
|
Participants' height will be measured using SECA stadiometer, and body weight will be measured using the SECA mBCA 515 (Seca, Hamburg, Germany), a valid and reliable analyzer of body composition.
Participants will drink 400 ml of water before the examination which will take place in the morning.
Drinking will be stopped 30 minutes before the examination and participants will be instructed to urinate and remove any jewelries before the examination.
|
Baseline to twelve weeks
|
|
Change in maximal muscle strength- One repetition maximum - leg curl and shoulder press
Time Frame: Baseline to twelve weeks
|
Participants will perform a dynamic warmup including mobility and calisthenics exercises, followed by specific warm up sets of each of the exercises leg curl and shoulder press (performed on weight-stack machines).
Then, up to five attempts will be made to complete one repetition sets with increasing load until the participant either fails to complete the full range of motion or declares she cannot attempt the next set.
The load (in kg) of the final successful attempt for each exercise will be documented for analysis.
Two to three minutes rest will be provided between the attempts.
The order of the exercises will be maintained throughout the assessment points and between participants.
The assessments will be carried out by the same experimenter at the same time of day ±2 hours.
|
Baseline to twelve weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Israel Halperin, PhD, Tel Aviv University
Publications and helpful links
General Publications
- Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.
- Westcott WL. Resistance training is medicine: effects of strength training on health. Curr Sports Med Rep. 2012 Jul-Aug;11(4):209-16. doi: 10.1249/JSR.0b013e31825dabb8.
- Bennie JA, De Cocker K, Smith JJ, Wiesner GH. The epidemiology of muscle-strengthening exercise in Europe: A 28-country comparison including 280,605 adults. PLoS One. 2020 Nov 25;15(11):e0242220. doi: 10.1371/journal.pone.0242220. eCollection 2020.
- Phillips SM, Winett RA. Uncomplicated resistance training and health-related outcomes: evidence for a public health mandate. Curr Sports Med Rep. 2010 Jul-Aug;9(4):208-13. doi: 10.1249/JSR.0b013e3181e7da73.
- Iwatsuki T, Abdollahipour R, Psotta R, Lewthwaite R, Wulf G. Autonomy facilitates repeated maximum force productions. Hum Mov Sci. 2017 Oct;55:264-268. doi: 10.1016/j.humov.2017.08.016. Epub 2017 Sep 1.
- Helms ER, Byrnes RK, Cooke DM, Haischer MH, Carzoli JP, Johnson TK, Cross MR, Cronin JB, Storey AG, Zourdos MC. RPE vs. Percentage 1RM Loading in Periodized Programs Matched for Sets and Repetitions. Front Physiol. 2018 Mar 21;9:247. doi: 10.3389/fphys.2018.00247. eCollection 2018.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ISF_Halperin_TAU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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