NCT05371587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 7, 2025

Status Verified

August 1, 2024

Enrollment Period

2.2 years

First QC Date

May 1, 2022

Last Update Submit

March 5, 2025

Conditions

Keywords

AutonomyPerception of effort

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (14)

  • Change in self efficacy questionnaire score

    Baseline to twelve weeks

  • Enjoyment

    Six weeks to twelve weeks

  • Adherence

    End of week 12

  • Adherence without incentive

    From week 12 to week 24

  • Change in total cholesterol value

    Baseline to twelve weeks

  • +9 more secondary outcomes

Study Arms (2)

A - Standard resistance training prescription

ACTIVE COMPARATOR

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: 1. Laboratory visit for measuring physiological and anthropometric outcomes (see outcomes section) 2. 1RM testing 3. Endurance and maximal voluntary contraction testing + introduction with the exercise program 4. A second introduction session with the exercise program

Other: Standard prescription

B- Autonomy and perceptions approach to resistance training (APART)

EXPERIMENTAL

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: 1. Laboratory visit (similar to standard). 2. 1RM testing where the principles of perceived effort will be introduced. 3. Endurance and maximal voluntary contraction testing + introduction with the exercise program. Participants will practice how to self-select the load they prefer and then perform repetitions leading to the target RPE score. 4. A second introduction session with the exercise program and the RPE construct.

Other: Autonomy and Perceptions Approach to Resistance Training (APART)

Interventions

Alternative resistance training prescription based on trainees' autonomy and perceptions.

B- Autonomy and perceptions approach to resistance training (APART)

Standard resistance training prescription, based on international organization's guidelines.

A - Standard resistance training prescription

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel, 4059100, Israel

Location

Related Publications (7)

  • 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.

    PMID: 22777332BACKGROUND
  • 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.

    PMID: 33237930BACKGROUND
  • 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.

    PMID: 20622538BACKGROUND
  • 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.

    PMID: 28865313BACKGROUND
  • 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.

    PMID: 23851406BACKGROUND
  • 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.

    PMID: 29628895BACKGROUND
  • Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

    PMID: 7154893BACKGROUND

Study Officials

  • Israel Halperin, PhD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are allocated using sealed envelops, they receive their arm identification "A" or "B" without information regarding the intervention or group differences. Data will be analyzed using the identification letter without treatment allocation information.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A parallel two-armed, non-inferiority randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 1, 2022

First Posted

May 12, 2022

Study Start

May 1, 2022

Primary Completion

June 30, 2024

Study Completion

December 1, 2024

Last Updated

March 7, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations