ExerciseREFLEXNCT04574674
Home-based REsistance vs a Home-based FLEXbility Exercise Programmes on Muscular Endurance and Flexibility in Adults
A study testing Flexibility exercise programme and Resistance exercise programme in people with Exercise, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
This study will evaluate the effects of a home-based resistance exercise programme v/s a home-based flexibility exercise programme on muscular endurance and flexibility on healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Flexibility exercise programme and Resistance exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Glasgow
Glasgow, G12 8TA
Jason Gill, PhD, 0141 330 ext. 2916, jason.gill@glasgow.ac.uk
Maria Fernanda Gabler Trisotti, MSc, 0141 330 ext. 7615, m.gabler-trisotti.1@research.gla.ac.uk
About this study
Official title: Effect of a Home-based REsistance Exercise vs a Home-based FLEXbility Exercise Programme on Muscular Endurance and Flexibility in Healthy Adults
This study will evaluate the effects of a home-based resistance exercise programme v/s a home-based flexibility exercise programme on muscular endurance and flexibility on healthy adults. Half of the participants will undergo a 12-weeks home-based resistance exercise programme while the other half will undergo a 12-week home-based flexibility exercise programme.
Read the 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.
- Conditions
- Exercise
- Being tested
- Flexibility exercise programme, Resistance exercise programme
- Keywords
- muscle endurance, muscle strength, muscular fitness, resistance training, strength training, physical activity, voluntary failure
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexibility exercise programmeBehavioural
Static passive flexibility exercises.
Resistance exercise programmeBehavioural
Body weight and resistance bands exercises.
| Study group | Role | What they receive |
|---|---|---|
| Flexibility exercise group | Experimental | 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. Receives: Behavioral: Flexibility exercise programme |
| Resistance exercise group | Experimental | 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. Receives: Behavioral: Resistance exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of press ups
Change in number of press ups
Measured: 0 -12 weeks
Secondary outcomes (11)
Number of press-ups
Change in the number of press ups
Measured: 0-6 weeks
Number of press-ups
Change in the number of press ups
Measured: 6-12 weeks
Time holding half-squat position
Change in the time holding half squat position
Measured: 0-12 weeks
Time holding half-squat position
Change in the time holding half squat position
Measured: 0-6 weeks
Time holding half-squat position
Change in the time holding half squat position
Measured: 6-12 weeks
Time holding plank position
Change in the time holding plank position
Measured: 0-12 weeks
Time holding plank position
Change in the time holding plank position
Measured: 0-6 weeks
Time holding plank position
Change in the time holding plank position
Measured: 6-12 weeks
Distance achieved in the sit-and-reach test
Change in distance achieved in the sit-and-reach test
Measured: 0-12 weeks
Distance achieved in the sit-and-reach test
Change in distance achieved in the sit-and-reach test
Measured: 0-6 weeks
Distance achieved in the sit-and-reach test
Change in distance achieved in the sit-and-reach test
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start6 Dec 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial with two groups, flexibility exercise group and resistance exercise group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Jason Gill, University of Glasgow
- Investigators
- Jason Gill, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574674
- Sponsor's protocol ID
- 200190188
- Acronym
- REFLEX
- Status last verified
- Aug 2021
- First submitted
- 28 Sep 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Home-based REsistance Exercise vs a Home-based FLEXbility Exercise Programme on Muscular Endurance and Flexibility in Healthy Adults
- ClinicalTrials.gov ID
- NCT04574674
- Acronym / sponsor ID
- REFLEX / 200190188
- Conditions
- Exercise
- Keywords
- muscle endurance, muscle strength, muscular fitness, resistance training, strength training, physical activity, voluntary failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 6 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of a home-based resistance exercise programme v/s a home-based flexibility exercise programme on muscular endurance and flexibility on healthy adults. Half of the participants will undergo a 12-weeks home-based resistance exercise programme while the other half will undergo a 12-week home-based flexibility exercise programme.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial with two groups, flexibility exercise group and resistance exercise group.
| Arm | Type | Receives |
|---|---|---|
| Flexibility exercise group | Experimental | Behavioral: Flexibility exercise programmeParticipants 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. |
| Resistance exercise group | Experimental | Behavioral: Resistance exercise programmeParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexibility exercise programmeStatic passive flexibility exercises. | Behavioural | Flexibility exercise group |
| Resistance exercise programmeBody weight and resistance bands exercises. | Behavioural | Resistance exercise group |
Primary outcome
Number of press ups
Time frame: 0 -12 weeks
Change in number of press ups
11 secondary outcomes
Number of press-ups
Time frame: 0-6 weeks
Number of press-ups
Time frame: 6-12 weeks
Time holding half-squat position
Time frame: 0-12 weeks
Time holding half-squat position
Time frame: 0-6 weeks
Time holding half-squat position
Time frame: 6-12 weeks
Time holding plank position
Time frame: 0-12 weeks
Time holding plank position
Time frame: 0-6 weeks
Time holding plank position
Time frame: 6-12 weeks
Distance achieved in the sit-and-reach test
Time frame: 0-12 weeks
Distance achieved in the sit-and-reach test
Time frame: 0-6 weeks
Distance achieved in the sit-and-reach test
Time frame: 6-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Gill, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexibility exercise programme and Resistance exercise programme in people with Exercise, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Gill, PhD (0141 330 ext. 2916, jason.gill@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of press ups (time frame: 0 -12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.