Clinical trial NCT05371587: The Effects of Autonomy and Perceptions on Resistance Training Outcomes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strength Training
Keywords: Autonomy
Perception of effort
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel two-armed, non-inferiority randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in systolic blood pressure
timeFrame: Baseline to twelve weeks
measure: Change in Low Density Lipoprotein (LDL) value
timeFrame: Baseline to twelve weeks
measure: Change in fasting glucose value
timeFrame: Baseline to twelve weeks
measure: Change in fat free mass
timeFrame: Baseline to twelve weeks
measure: Change in waist circumference
timeFrame: Baseline to twelve weeks
measure: Change in maximal muscle strength- One repetition maximum
timeFrame: Baseline to twelve weeks
measure: Change in muscle endurance
timeFrame: Baseline to twelve weeks
measure: Change in maximum voluntary contraction (MVC) - knee extension
timeFrame: Baseline to twelve weeks
Secondary outcomes:
measure: Change in self efficacy questionnaire score
timeFrame: Baseline to twelve weeks
measure: Enjoyment
timeFrame: Six weeks to twelve weeks
measure: Adherence
timeFrame: End of week 12
measure: Adherence without incentive
timeFrame: From week 12 to week 24
measure: Change in total cholesterol value
timeFrame: Baseline to twelve weeks
measure: Change in maximum voluntary contraction (MVC) - horizontal row
timeFrame: Baseline to twelve weeks
measure: Change in Hemoglobin
timeFrame: Baseline to twelve weeks
measure: Change in maximum voluntary contraction (MVC) - horizontal row
timeFrame: Baseline to twelve weeks
measure: Change in High Density Lipoprotein (HDL) value
timeFrame: Baseline to twelve weeks
measure: Change in triglycerides value
timeFrame: Baseline to twelve weeks
measure: Change in stroke volume
timeFrame: Baseline to twelve weeks
measure: Change in fat percentage
timeFrame: Baseline to twelve weeks
measure: Change in body mass index (BMI)
timeFrame: Baseline to twelve weeks
measure: Change in maximal muscle strength- One repetition maximum - leg curl and shoulder press
timeFrame: Baseline to twelve weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Israel Halperin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.
citation: Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.