Frail Elderly SyndromeNCT03627793
Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study
A study testing resistance training in people with Frail Elderly Syndrome, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
After the age of 40-45 years muscle mass and function progressively decline, reducing older peoples' abilities to perform tasks of daily living and also increase the risk of falls. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Aug 2018to 29 Nov 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
- Non-frail - Over 65 years of age Frail - Over 65 years of age, Three or more of the following criteria: >10lbs of weight loss unintentionally in previous year; grip strength in lowest 20% (by sex and BMI); self-reported exhaustion; walking time for 15 feet in slowest 20% (by sex and height); physical activity in the lowest 20%.
Who cannot join
- Non-frail - Current participation in an exercise programme. Clinical team do not think resistance exercise would be safe or unable to consent. Any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in Geriatric Medicine where required.
- Frail - Current participation in an exercise programme. Clinical team do not think resistance exercise would be safe or unable to consent. Any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in Geriatric Medicine where required.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Glasgow Royal Infirmary
Glasgow
Evan Campbell, PhD, 0141 330 3076, evan.campbell@glasgow.ac.uk
About this study
After the age of 40-45 years muscle mass and function progressively decline, reducing older peoples' abilities to perform tasks of daily living and also increase the risk of falls. It is known that, across the life course, resistance exercise can be of benefit in increasing muscle mass and function, yet how hard the exercise should be performed has received little attention. Current recommendations are for older people to perform exercise at 70% of the maximum they can lift, quite a high intensity that often puts older people off participating. Recent evidence in younger people has suggested that such intensities are not required.
The investigators aim to determine the feasibility of a study to investigate recruitment and adherence of older people to a study of exercise training at different intensities.
Read the detailed description
The cohort will comprise two sets of participants: frail older adults and non-frail older adults.
Each participant will receive 8 weeks of twice weekly supervised resistance training. Both the frail and non-frail participants will be randomised into either receiving high load resistance training or low load resistance training. High load resistance training will be delivered at 70% of the participants maximal capacity and low load resistance training will be delivered at 30% of maximal capacity. All resistance training will focus on the lower limb and regardless of intensity each exercise will be done to failure (unable to complete another full repetition).
- Conditions
- Frail Elderly Syndrome
- Being tested
- resistance training
- Keywords
- frailty, exercise, resistance training, strength, older adults
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance trainingOther
Moving muscles against loads with the purpose of increasing strength.
| Study group | Role | What they receive |
|---|---|---|
| High load non-frail | Active comparator | Non-frail participants who will receive resistance training at 70% of their maximal strength Receives: Other: resistance training |
| low load non-frail | Active comparator | Non-frail participants who will receive resistance training at 30% of their maximal strength Receives: Other: resistance training |
| high load frail | Experimental | Frail participants who will receive resistance training at 70% of their maximal strength Receives: Other: resistance training |
| low load frail | Experimental | Frail participants who will receive resistance training at 30% of their maximal strength Receives: Other: resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of training sessions attended
Expressed as a percentage of number of sessions attended
Measured: 8 weeks
Compliance with protocol
Expressed as a percentage of number of sessions where training protocol was adhered to
Measured: 8 weeks
Number of treatment-related adverse events as assessed by CTCAE v4.0
Number of adverse events that could be attributed to the intervention
Measured: 8 weeks
Acceptability of intervention (qualitative)
focus groups with semi-structured discussion plans will investigate the acceptability of the intervention
Measured: 8 weeks
Secondary outcomes (9)
Muscle thickness
Thickness of vastus lateralus using ultrasound (mm)
Measured: 8 weeks
Muscle power
Maximum voluntary contraction of a muscle at a set angle to produce a torque (kg)
Measured: 8 weeks
Muscle strength
Maximal load participant can lift (kg)
Measured: 8 weeks
Frailty
As measured by the Fried criteria. These are low energy expenditure, slow gait speed, weak grip strength, exhaustion, and unintentional weight loss. Fulfilling three of these criteria indicates clinical frailty.
Measured: 8 weeks
Quality of life
Measured using the Euroqol EQ-5 Dimension- 5 Level self report measure. This scale measures quality of life in 5 dimensions and produces an index of quality of life rangin from a worst quality of life at -1 to best quality of life at 1.
Measured: 8 weeks
Activities of daily living
Measured using the Barthel index. This scale measures ten variables of activities of daily living and produces an overall score. This ranges from 0-20 with a higher score indicating greater independence.
Measured: 8 weeks
Activities of daily living
Measured using the Lawton ADL scale. this self report measures assess independence in daily living in 8 different domains but produces an overall score. Scores range from 0-8 with 8 indicating full independence.
Measured: 8 weeks
Functional abilities
Short performance battery test. This battery of tests assesses balance, gait speed and lower limb strength. Scores are awarded for each individual section and aggregated ranging from 0-12 with a higher score indicating greater physical capability.
Measured: 8 weeks
motion analysis
biomechanical assessment using infr-red motion analysis cameras
Measured: 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 2018
- Study start21 Aug 2018
- Primary completion29 Nov 2019 (estimated)
- Study completion29 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies 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
- RCT
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Responsible party
- Principal investigator, Dr Evan Campbell, University of Glasgow
- Investigators
- Evan Campbell, PhD, Principal investigator, Univeristy of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627793
- Sponsor's protocol ID
- 3.0
- Status last verified
- Oct 2018
- First submitted
- 2 Aug 2018
- Last updated
- 11 Oct 2018
- 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 11 Oct 2018. 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
- NCT03627793
- Acronym / sponsor ID
- 3.0
- Conditions
- Frail Elderly Syndrome
- Keywords
- frailty, exercise, resistance training, strength, older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 29 Nov 2019 (estimated)
- Study completion
- 29 Nov 2019 (estimated)
- First posted
- 13 Aug 2018 (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.
After the age of 40-45 years muscle mass and function progressively decline, reducing older peoples' abilities to perform tasks of daily living and also increase the risk of falls. It is known that, across the life course, resistance exercise can be of benefit in increasing muscle mass and function, yet how hard the exercise should be performed has received little attention. Current recommendations are for older people to perform exercise at 70% of the maximum they can lift, quite a high intensity that often puts older people off participating. Recent evidence in younger people has suggested that such intensities are not required.
The investigators aim to determine the feasibility of a study to investigate recruitment and adherence of older people to a study of exercise training at different intensities.
Detailed description
The cohort will comprise two sets of participants: frail older adults and non-frail older adults.
Each participant will receive 8 weeks of twice weekly supervised resistance training. Both the frail and non-frail participants will be randomised into either receiving high load resistance training or low load resistance training. High load resistance training will be delivered at 70% of the participants maximal capacity and low load resistance training will be delivered at 30% of maximal capacity. All resistance training will focus on the lower limb and regardless of intensity each exercise will be done to failure (unable to complete another full repetition).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| High load non-frail | Active comparator | Other: resistance trainingNon-frail participants who will receive resistance training at 70% of their maximal strength |
| low load non-frail | Active comparator | Other: resistance trainingNon-frail participants who will receive resistance training at 30% of their maximal strength |
| high load frail | Experimental | Other: resistance trainingFrail participants who will receive resistance training at 70% of their maximal strength |
| low load frail | Experimental | Other: resistance trainingFrail participants who will receive resistance training at 30% of their maximal strength |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Non-frail - Over 65 years of age Frail - Over 65 years of age, Three or more of the following criteria: >10lbs of weight loss unintentionally in previous year; grip strength in lowest 20% (by sex and BMI); self-reported exhaustion; walking time for 15 feet in slowest 20% (by sex and height); physical activity in the lowest 20%.
Key exclusion criteria (2 listed)
- Non-frail - Current participation in an exercise programme. Clinical team do not think resistance exercise would be safe or unable to consent. Any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in Geriatric Medicine where required.
- Frail - Current participation in an exercise programme. Clinical team do not think resistance exercise would be safe or unable to consent. Any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in Geriatric Medicine where required.
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 |
|---|---|---|
| resistance trainingMoving muscles against loads with the purpose of increasing strength. | Other | High load non-frail, high load frail, low load frail, low load non-frail |
Primary outcome
Number of training sessions attended
Time frame: 8 weeks
Expressed as a percentage of number of sessions attended
Compliance with protocol
Time frame: 8 weeks
Expressed as a percentage of number of sessions where training protocol was adhered to
Number of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 8 weeks
Number of adverse events that could be attributed to the intervention
Acceptability of intervention (qualitative)
Time frame: 8 weeks
focus groups with semi-structured discussion plans will investigate the acceptability of the intervention
9 secondary outcomes
Muscle thickness
Time frame: 8 weeks
Muscle power
Time frame: 8 weeks
Muscle strength
Time frame: 8 weeks
Frailty
Time frame: 8 weeks
Quality of life
Time frame: 8 weeks
Activities of daily living
Time frame: 8 weeks
Activities of daily living
Time frame: 8 weeks
Functional abilities
Time frame: 8 weeks
motion analysis
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- 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.
Evan Campbell, PhD principal investigator
Univeristy 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 resistance training in people with Frail Elderly Syndrome, 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: status not confirmed, as of the sponsor's last update on 11 Oct 2018. 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 Evan Campbell, PhD (0141 330 3076, campbell.evan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of training sessions attended (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 11 Oct 2018.