The Effects of Autonomy and Perceptions on Resistance Training Outcomes

Strength Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371587
• Other study ID #: ISF_Halperin_TAU
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Tel Aviv University
• Contact: Hadar Schwartz, MSc
• Phone: +972-54-5921625
• Email: hadarsc[@]tauex.tau.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

120 participants will be randomized into one of two groups that will perform resistance training at a gym three time per week for three months. One group will follow common resistance training guidelines, whereas the other will exercise according to their preferences and perception of effort. The groups will be compared on the following primary outcomes after six and 12 weeks: body composition, physiological and performance tests. The groups will be compared on the following secondary outcomes every two weeks: enjoyment and satisfaction levels. Adherence rates will be measured throughout the intervention.

Description:

Develop and test the non-inferiority of a new RT prescription model, entitled The Autonomy and Perceptions Approach to Resistance Training (APART). This approach is simple to follow, individualized, and autonomy supportive. Accordingly, it may assist trainees to overcome some of the limitations of the standard RT prescription approach. Under APART, trainees choose the loads they lift for each exercise according to their preferences, and then complete as many repetitions as required until reaching a specific rating of perceived effort (RPE) value on a 0 (no effort) to 10 (maximal effort) scale (e.g., 8/10). For this non-inferiority randomized controlled trial, the investigators will recruit 120 healthy, sedentary participants, between the ages of 18 and 45, who will be block-randomized by gender and age (18-27, 28-45) to either the APART or the standard groups. Following two baseline-testing sessions and two guided familiarization sessions, participants will independently complete three RT sessions per week for 12 weeks. The following primary outcomes will be assessed after six and 12 weeks: (ⅰ) body composition including fat free mass; (ⅱ) performance measures, including maximal strength and strength endurance; and (ⅲ) physiological measures, including blood profile and hemodynamics. The following secondary outcomes will be measured every two weeks: (ⅳ) psychological measures, including self-efficacy, autonomy, and enjoyment; and (ⅴ) adherence measures, which will be monitored throughout the intervention. If APART will be found to be non-inferior to the standard RT prescription, it can provide a simple and easy to follow alternative to the standard RT prescriptions, which also highlights trainees' preferences and individual abilities. This, in turn, might contribute to future participation and adherence to RT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Strength Training

Intervention

Other:
• Autonomy and Perceptions Approach to Resistance Training (APART)
Alternative resistance training prescription based on trainees' autonomy and perceptions.
• Standard prescription
Standard resistance training prescription, based on international organization's guidelines.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (7)

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. — View Citation

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure	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
Primary	Change in Low Density Lipoprotein (LDL) value	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
Primary	Change in fasting glucose value	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
Primary	Change in fat free mass	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
Primary	Change in waist circumference	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
Primary	Change in maximal muscle strength- One repetition maximum	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
Primary	Change in muscle endurance	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
Primary	Change in maximum voluntary contraction (MVC) - knee extension	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	Change in self efficacy questionnaire score	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
Secondary	Enjoyment	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
Secondary	Adherence	Number of entries to the gym, documented by the gym front desk	End of week 12
Secondary	Adherence without incentive	Number of entries to the gym, documented by the gym front desk	From week 12 to week 24
Secondary	Change in total cholesterol value	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
Secondary	Change in maximum voluntary contraction (MVC) - horizontal row	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
Secondary	Change in Hemoglobin	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
Secondary	Change in maximum voluntary contraction (MVC) - horizontal row	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
Secondary	Change in High Density Lipoprotein (HDL) value	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
Secondary	Change in triglycerides value	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
Secondary	Change in stroke volume	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
Secondary	Change in fat percentage	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
Secondary	Change in body mass index (BMI)	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
Secondary	Change in maximal muscle strength- One repetition maximum - leg curl and shoulder press	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