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Lower Limb Resistance Training in Older Inpatients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02141126
Enrollment
60
Registered
2014-05-19
Start date
2013-07-01
Completion date
2019-09-01
Last updated
2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Weakness

Keywords

Older adults, Strength training, Muscle mass, Function, Inpatients

Brief 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 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

Interventions

OTHERResistance training

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.

OTHERUsual care

Standard inpatient 'usual care' physiotherapy

Sponsors

St. James's Hospital, Ireland
CollaboratorOTHER
Royal College of Surgeons, Ireland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Feasibility study Randomised and controlled

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Lower limb dynamometryBaseline, Week 6Lower 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.

Secondary

MeasureTime frameDescription
Six Minute Walk Test (6MWT)Baseline, Week 6Six 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.
Functional mobility using the Timed Up and Go (TUG)Baseline, Week 6Functional 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.
EuroQol-5D (EQ-5D)Baseline, Week 6EuroQol-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.
Canadian Study of Health and Ageing Clinical Frailty Scale (CFS)Baseline, Week 6Canadian 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).

Other

MeasureTime frameDescription
Grip StrengthBaseline, Week 6Grip strength will be measured using a handgrip dynamometer on the non-dominant arm (Clinifeed/Roussel dynamometer).
Skeletal muscle massBaseline, Week 6Skeletal muscle mass will be calculated using a validated equation based on measured bioimpedance from the body composition scales (Janssen J Appl Phil 2000).
Height and Weight and BMIBaseline, Week 6Height will be measured from ulna length (BAPEN, 2004), weight will be measured using body composition scales, and body mass index (BMI) calculated using these measures.

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026