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临床试验/NCT05371587
NCT05371587已完成不适用

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

Tel Aviv University1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
1
主要终点
Change in waist circumference

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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).

排除标准

  • •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)

研究组 & 干预措施

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

干预措施: Standard prescription (Other)

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.

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

结局指标

主要结局

Change in waist circumference

时间窗: 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.

Change in systolic blood pressure

时间窗: 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.

Change in muscle endurance

时间窗: 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.

Change in maximum voluntary contraction (MVC) - knee extension

时间窗: 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.

Change in Low Density Lipoprotein (LDL) value

时间窗: 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.

Change in maximal muscle strength- One repetition maximum

时间窗: 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.

Change in fasting glucose value

时间窗: 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

Change in fat free mass

时间窗: 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.

次要结局

  • Change in maximum voluntary contraction (MVC) - horizontal row(Baseline to twelve weeks)
  • Adherence(End of week 12)
  • Adherence without incentive(From week 12 to week 24)
  • Change in triglycerides value(Baseline to twelve weeks)
  • Change in fat percentage(Baseline to twelve weeks)
  • Change in body mass index (BMI)(Baseline to twelve weeks)
  • Change in High Density Lipoprotein (HDL) value(Baseline to twelve weeks)
  • Change in stroke volume(Baseline to twelve weeks)
  • Change in total cholesterol value(Baseline to twelve weeks)
  • Change in self efficacy questionnaire score(Baseline to twelve weeks)
  • Enjoyment(Six weeks to twelve weeks)
  • Change in Hemoglobin(Baseline to twelve weeks)
  • Change in maximal muscle strength- One repetition maximum - leg curl and shoulder press(Baseline to twelve weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Israel Halperin

Principle investigator

Tel Aviv University

研究点 (1)

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