SarcopeniaNCT04053920
Resistance Exercise Training at Different Intensities
A study testing Low Load Resistance exercise and High Load Resistance exercise in people with Sarcopenia and Frailty, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The aim of the current study, therefore, is to determine the feasibility of recruitment and adherence to resistance exercise training interventions performed at low and high loads, to volitional muscular failure, in a trial population that includes both healthy and frail older people. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Frailty, Aging
- What is being tested?
- Low Load Resistance exercise and High Load Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2018to 18 Dec 2019
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Over age of 65 years
Who cannot join
- Current participation in an exercise programme
- Exercise deemed unsafe by clinical team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study
The aim of the current study, therefore, is to determine the feasibility of recruitment and adherence to resistance exercise training interventions performed at low and high loads, to volitional muscular failure, in a trial population that includes both healthy and frail older people.
- Conditions
- Sarcopenia, Frailty, Aging
- Being tested
- Low Load Resistance exercise, High Load Resistance exercise
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Load Resistance exerciseBehavioural
leg extension, leg press, leg curl and calf press
High Load Resistance exerciseBehavioural
leg extension, leg press, leg curl and calf press
| Study group | Role | What they receive |
|---|---|---|
| Low load | Experimental | Training at 30-40% one-repetition maximum (1RM) Receives: Behavioral: Low Load Resistance exercise |
| High load | Experimental | Training at 65-75% one-repetition maximum (1RM) Receives: Behavioral: High Load Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Knee extensor maximal torque during an isometric MVC
Measured: Change from baseline to 8 weeks
Secondary outcomes (6)
Vastus lateralis muscle thickness
Measured via ultrasound
Measured: Change from baseline to 8 weeks
Muscle strength
Knee flexor maximal torque during an isometric MVC
Measured: Change from baseline to 8 weeks
One-repetition maximum
leg extension, leg curl, leg press and calf press
Measured: Change from baseline to 8 weeks
Biomechanics during walking and stair climbing
Motion analysis
Measured: Change from baseline to 8 weeks
Short performance physical battery test
SPPB - balance, walking pace and chair rise
Measured: Change from baseline to 8 weeks
Quality of life measure
EQ-5D-5L questionnaire
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Mar 2018
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Gray, University of Glasgow
- Investigators
- Stuart Gray, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053920
- Sponsor's protocol ID
- 236559
- Status last verified
- Mar 2020
- First submitted
- 9 Aug 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04053920
- Acronym / sponsor ID
- 236559
- Conditions
- Sarcopenia, Frailty, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 13 Aug 2019 (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.
The aim of the current study, therefore, is to determine the feasibility of recruitment and adherence to resistance exercise training interventions performed at low and high loads, to volitional muscular failure, in a trial population that includes both healthy and frail older people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low load | Experimental | Behavioral: Low Load Resistance exerciseTraining at 30-40% one-repetition maximum (1RM) |
| High load | Experimental | Behavioral: High Load Resistance exerciseTraining at 65-75% one-repetition maximum (1RM) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Over age of 65 years
Key exclusion criteria (2 listed)
- Current participation in an exercise programme
- Exercise deemed unsafe by clinical team
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 |
|---|---|---|
| Low Load Resistance exerciseleg extension, leg press, leg curl and calf press | Behavioural | Low load |
| High Load Resistance exerciseleg extension, leg press, leg curl and calf press | Behavioural | High load |
Primary outcome
Muscle strength
Time frame: Change from baseline to 8 weeks
Knee extensor maximal torque during an isometric MVC
6 secondary outcomes
Vastus lateralis muscle thickness
Time frame: Change from baseline to 8 weeks
Muscle strength
Time frame: Change from baseline to 8 weeks
One-repetition maximum
Time frame: Change from baseline to 8 weeks
Biomechanics during walking and stair climbing
Time frame: Change from baseline to 8 weeks
Short performance physical battery test
Time frame: Change from baseline to 8 weeks
Quality of life measure
Time frame: Change from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Stuart Gray 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 Low Load Resistance exercise and High Load Resistance exercise in people with Sarcopenia and Frailty, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 25 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: Change from baseline to 8 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 25 Mar 2020.