- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04574674
Home-based REsistance vs a Home-based FLEXbility Exercise Programmes on Muscular Endurance and Flexibility in Adults (REFLEX)
Effect of a Home-based REsistance Exercise vs a Home-based FLEXbility Exercise Programme on Muscular Endurance and Flexibility in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Regular resistance training can lead to a variety of health benefits including increases in muscle size and strength, reductions on body fat, increased metabolic rate, glycaemic control, decreased blood pressure and improved blood lipid profiles. Because of this, current physical activity guidelines recommend undertaking muscle strengthening activities involving major muscle groups two days a week or more, alongside at least 150 minutes per week of moderate intensity physical activity (or 75 minutes per week of vigorous intensity physical activity). However, only small portion of the population achieves the muscle strengthening aspect of the guidelines.
Why participation in muscle-strengthening exercise is low is not clear but people identify several barriers including the lack of time, the effort involved, lack of purpose, pain due to injury, negative experiences of prescriptive exercise, apathy, illness, injury inclement weather and work commitment. In addition, some women have expressed a worry of looking 'manly' or 'bulking up' if they undertake resistance exercise. A further potential barrier is lack of access to a gym with appropriate equipment to perform resistance exercise, or dislike of a gym setting. Thus, identifying approaches to find a safe, enjoyable and accessible programme that minimises the burden of performing resistance exercise, and identifying a minimal amount of resistance training which can provide benefits is a key issue which could help more people to undertake muscle strengthening exercises.
Meta-analyses indicate that while performing resistance exercise two or more times per week of resistance exercise per muscle group appears to be optimal to maximise strength gains, a single set of resistance exercise per muscle group per week, if performed to failure is sufficient to induce substantial strength changes.
The main aim of this study is to compare the effects of an app-based home-based resistance exercise programme vs a home-based flexibility programme on muscular endurance (number of press-ups, time achieved in half-squat test, and time achieved in plank test, assessed online during a zoom call) and flexibility (sit and reach, assessed online during a zoom call) in healthy adults. Secondary aims are a) to determine participants' adherence to both exercise programmes, b) to determine participants' choice of weekly exercise volume (compared to minimum prescription) in both exercise programmes c) to determine participants' distribution of exercise throughout the week in both exercise programmes d) to determine the effects of a exercise programmes on well-being, and finally e) to determine participants' perceptions, feelings, thoughts, enjoyment, tolerance and acceptability of both exercise programmes.
The study is a randomized control trial in which the flexibility exercise group will undergo a 12-week home-based flexibility exercise programme. The resistance exercise group will undergo a 12-week home-based resistance exercise programme. Participants will be asked to perform a minimum amount of resistance or flexibility exercise of 1 set/week for each of six exercises and will have the opportunity to increase their volume of exercise to 2 sets or 3 sets/week per exercise if it is their choice. In addition, participants will be able to distribute the exercises during the week according to their preference (all in one day or spread over several days of the week, etc.). Participants will be encouraged to have a minimum of one day of rest per week.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Fernanda Gabler, MSc
- Phone Number: 7615 0141 330
- Email: m.gabler-trisotti.1@research.gla.ac.uk
Study Locations
-
-
-
Glasgow, United Kingdom, G12 8TA
- Recruiting
- University of Glasgow
-
Contact:
- Maria Fernanda Gabler Trisotti, MSc
- Phone Number: 7615 0141 330
- Email: m.gabler-trisotti.1@research.gla.ac.uk
-
Sub-Investigator:
- Maria Fernanda Gabler Trisotti, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-64 years old.
- Perform 30 minutes or more of aerobic vigorous physical activity per week.
- Do not to perform any kind of resistance exercise.
Exclusion Criteria:
- Failure of the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
- Perform 30 minutes or more of vigorous intensity exercise from the International Physical Activity Questionnaire (IPAQ)
- To have a job that compromises manual labour
- History of cardiovascular disease
- Diabetes
- Any other illness that would prevent the participation in a resistance exercise or flexibility exercise programme.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Flexibility exercise group
Participants will be asked to follow a 12-week flexibility exercise training programme. Participants will be asked to perform a minimum amount of flexibility exercise of 1 set/week for each of six exercises and will have the opportunity to increase their volume of exercise to 2 sets or 3 sets/week per exercise if it is their choice. Participants will perform 6 flexibility exercises per week (2 different for legs, 1 shoulder and arms, 1 chest, 1 back and 1 core). Passive static stretching exercises will be performed. |
Static passive flexibility exercises.
|
|
EXPERIMENTAL: Resistance exercise group
Participants will be asked to follow a 12-week home-based exercise programme. Participants will be asked to perform a minimum amount of resistance exercise of 1 set/week for each of six exercises and will have the opportunity to increase their volume of exercise to 2 sets or 3 sets/week per exercise if it is their choice. Participants in the resistance exercise group will be asked to perform a total of 6 exercises per week (2 different leg exercises, 1 shoulder exercise, 1 chest exercise, 1 back exercise and 1 core exercise). Body weight and resistance bands exercises will be used. Participants will be asked to perform each set to complete as many repetitions as possible until fatigue. |
Body weight and resistance bands exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of press ups
Time Frame: 0 -12 weeks
|
Change in number of press ups
|
0 -12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of press-ups
Time Frame: 0-6 weeks
|
Change in the number of press ups
|
0-6 weeks
|
|
Number of press-ups
Time Frame: 6-12 weeks
|
Change in the number of press ups
|
6-12 weeks
|
|
Time holding half-squat position
Time Frame: 0-12 weeks
|
Change in the time holding half squat position
|
0-12 weeks
|
|
Time holding half-squat position
Time Frame: 0-6 weeks
|
Change in the time holding half squat position
|
0-6 weeks
|
|
Time holding half-squat position
Time Frame: 6-12 weeks
|
Change in the time holding half squat position
|
6-12 weeks
|
|
Time holding plank position
Time Frame: 0-12 weeks
|
Change in the time holding plank position
|
0-12 weeks
|
|
Time holding plank position
Time Frame: 0-6 weeks
|
Change in the time holding plank position
|
0-6 weeks
|
|
Time holding plank position
Time Frame: 6-12 weeks
|
Change in the time holding plank position
|
6-12 weeks
|
|
Distance achieved in the sit-and-reach test
Time Frame: 0-12 weeks
|
Change in distance achieved in the sit-and-reach test
|
0-12 weeks
|
|
Distance achieved in the sit-and-reach test
Time Frame: 0-6 weeks
|
Change in distance achieved in the sit-and-reach test
|
0-6 weeks
|
|
Distance achieved in the sit-and-reach test
Time Frame: 6-12 weeks
|
Change in distance achieved in the sit-and-reach test
|
6-12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
- 200190188
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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