Muscle WeaknessNCT02141126
Lower Limb Resistance Training in Older Inpatients
A study testing Resistance training in people with Muscle Weakness, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
The primary aim of this feasibility study is to evaluate the feasibility of delivering a PRT programme in an inpatient older person rehabilitation setting and to describe changes in lower limb strength and physical function following six weeks of resistance training and routine physiotherapy versus a control group of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jul 2013to 1 Sep 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
- No healthy volunteers
- Older adult
Who may be able to join
- Patients, male and female elderly inpatients 65 years.
- Patients must be medically stable.
- Patients who are able to follow one-stage commands.
- Patients must be able to give informed consent.
Who cannot join
- Unstable medical condition.
- Patients who are unable to follow one-stage commands.
- Acute pain or fracture
- Patients who are unable to stand or require more than assistance of two staff to mobilise/transfer.
- Patients who have been admitted with a recent diagnosis of stroke, due to their varying patterns of recovery.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Physiotherapy Department, St James's Hospital, James's Street, Dublin 8, Ireland
Dublin, 8
About this study
Official title: Can Lower Limb Resistance Training Improve Strength, Muscle Mass and Functional Outcomes in Older Inpatients in a Post-acute Rehabilitation Unit? A Randomised Controlled Feasibility Study
The primary aim of this feasibility study is to evaluate the feasibility of delivering a PRT programme in an inpatient older person rehabilitation setting and to describe changes in lower limb strength and physical function following six weeks of resistance training and routine physiotherapy versus a control group of routine physiotherapy only in an older inpatient population.
Read the detailed description
This is a prospective, single blinded, randomised controlled feasibility study recruiting consecutive appropriate patients in this post-acute rehabilitation unit.
Feasibility outcomes including safety, recruitment, measurements, adherence, retention and satisfaction will be evaluated. There are two groups (i) exercise intervention and (ii) control. It will not be possible to blind the treating physiotherapist or the patient to the exercise intervention; hence the single (assessor) blinded design.
The study will be based in St James's Hospital, Dublin. Assessments and the delivery of the exercise intervention will be conducted in the Physiotherapy department.
Patients will be recruited in the inpatient setting. Appropriate patients will be approached, and the intervention explained to them. The patient will be given an information leaflet and 24-hours to consider involvement in the study
- Conditions
- Muscle Weakness
- Being tested
- Resistance training, Usual care
- Keywords
- Older adults, Strength training, Muscle mass, Function, Inpatients
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Usual physiotherapy care and twice weekly tailored and progressive resistance lower limb exercises Circuit-type format, sessions will last 35 minutes and will include a warm-up and cool-down period. Exercises tailored to each patient and will use ankle weights as the resistance, using 65-75% of their 1-Repetition Maximum. Intervention will last for 6 weeks.
Usual careOther
Standard inpatient 'usual care' physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Usual care and resistance exercises. Receives: Other: Resistance training |
| Usual care | Other | Usual inpatient physiotherapy Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb dynamometry
Lower limb dynamometry will be measured using the Power Track II Commander by J-Tech Medical. A previous study in this rehabilitation unit has determined that this is a reliable measure of lower limb strength in this population. The primary outcome measurement will be quadriceps muscle strength.
Measured: Baseline, Week 6
Secondary outcomes (4)
Functional mobility using the Timed Up and Go (TUG)
Functional mobility using the Timed Up and Go (TUG) - this is a test of basic functional mobility for frail elderly people. The patient is asked to stand up from a chair, walk three metres, turn around and return to the chair, while being timed by the assessor.
Measured: Baseline, Week 6
Six Minute Walk Test (6MWT)
Six Minute Walk Test (6MWT) - this is a performance-based test. The distance walked in six minutes is measured and reported in metres or feet and is an indication of exercise tolerance.
Measured: Baseline, Week 6
EuroQol-5D (EQ-5D)
EuroQol-5D (EQ-5D) - measures health related quality of life, it contains a visual analogue scale (0 to 100, representing dead to excellent health state) and five items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: Baseline, Week 6
Canadian Study of Health and Ageing Clinical Frailty Scale (CFS)
Canadian Study of Health and Ageing Clinical Frailty Scale (CFS) - this is a measure of frailty based on clinical judgement. It is an ordinal scale which ranges from 1 to 7. Reliability and validity have been proven in an older population (Rockwood et al, 2005).
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study start1 Jul 2013
- Primary completion30 Jun 2014
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies 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
- Feasibility study Randomised and controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- St. James's Hospital, Ireland
- Responsible party
- Sponsor
- Investigators
- Sinead Coleman, MSc, Principal investigator, St James's Hospital, James's Street, Dublin 8, IrelandFrances Horgan, PhD, Principal investigator, Royal College of Surgeons in IrelandNiamh Murphy, MSc, Study director, St James's Hospital, James's Street, Dublin 8, IrelandGareth Clifford, MSc, Study director, St James's Hospital, James's Street, Dublin 8, IrelandDavid Robinson, MD, Study director, St James's Hospital, James's Street, Dublin 8, IrelandConal Cunningham, MD, Study director, St James's Hospital, James's Street, Dublin 8, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141126
- Sponsor's protocol ID
- RCSI-SJH
- Other IDs
- RCSI-SJH-MISA, RCSI-SJH-MISA-2013
- Status last verified
- Apr 2017
- First submitted
- 6 Jan 2014
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Lower Limb Resistance Training Improve Strength, Muscle Mass and Functional Outcomes in Older Inpatients in a Post-acute Rehabilitation Unit? A Randomised Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT02141126
- Acronym / sponsor ID
- RCSI-SJH
- Conditions
- Muscle Weakness
- Keywords
- Older adults, Strength training, Muscle mass, Function, Inpatients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- St. James's Hospital, Ireland
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 19 May 2014 (estimated)
- 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 primary aim of this feasibility study is to evaluate the feasibility of delivering a PRT programme in an inpatient older person rehabilitation setting and to describe changes in lower limb strength and physical function following six weeks of resistance training and routine physiotherapy versus a control group of routine physiotherapy only in an older inpatient population.
Detailed description
This is a prospective, single blinded, randomised controlled feasibility study recruiting consecutive appropriate patients in this post-acute rehabilitation unit.
Feasibility outcomes including safety, recruitment, measurements, adherence, retention and satisfaction will be evaluated. There are two groups (i) exercise intervention and (ii) control. It will not be possible to blind the treating physiotherapist or the patient to the exercise intervention; hence the single (assessor) blinded design.
The study will be based in St James's Hospital, Dublin. Assessments and the delivery of the exercise intervention will be conducted in the Physiotherapy department.
Patients will be recruited in the inpatient setting. Appropriate patients will be approached, and the intervention explained to them. The patient will be given an information leaflet and 24-hours to consider involvement in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Feasibility study Randomised and controlled
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Other: Resistance trainingUsual care and resistance exercises. |
| Usual care | Other | Other: Usual careUsual inpatient physiotherapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients, male and female elderly inpatients 65 years.
- Patients must be medically stable.
- Patients who are able to follow one-stage commands.
- Patients must be able to give informed consent.
Key exclusion criteria (5 listed)
- Unstable medical condition.
- Patients who are unable to follow one-stage commands.
- Acute pain or fracture
- Patients who are unable to stand or require more than assistance of two staff to mobilise/transfer.
- Patients who have been admitted with a recent diagnosis of stroke, due to their varying patterns of recovery.
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 trainingUsual physiotherapy care and twice weekly tailored and progressive resistance lower limb exercises Circuit-type format, sessions will last 35 minutes and will include a warm-up and cool-down period. Exercises tailored to each patient and will use ankle weights as the resistance, using 65-75% of their 1-Repetition Maximum. Intervention will last for 6 weeks. | Other | Resistance training |
| Usual careStandard inpatient 'usual care' physiotherapy | Other | Usual care |
Primary outcome
Lower limb dynamometry
Time frame: Baseline, Week 6
Lower limb dynamometry will be measured using the Power Track II Commander by J-Tech Medical. A previous study in this rehabilitation unit has determined that this is a reliable measure of lower limb strength in this population. The primary outcome measurement will be quadriceps muscle strength.
4 secondary outcomes
Functional mobility using the Timed Up and Go (TUG)
Time frame: Baseline, Week 6
Six Minute Walk Test (6MWT)
Time frame: Baseline, Week 6
EuroQol-5D (EQ-5D)
Time frame: Baseline, Week 6
Canadian Study of Health and Ageing Clinical Frailty Scale (CFS)
Time frame: Baseline, Week 6
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 12 Mar 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.
Sinead Coleman, MSc principal investigator
St James's Hospital, James's Street, Dublin 8, Ireland
Frances Horgan, PhD principal investigator
Royal College of Surgeons in Ireland
Niamh Murphy, MSc study director
St James's Hospital, James's Street, Dublin 8, Ireland
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 Muscle Weakness, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 4 inclusion and 5 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 12 Mar 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 Ireland. 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?
Lower limb dynamometry (time frame: Baseline, Week 6). 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 12 Mar 2021.