Clinical trial NCT02141126: Lower Limb Resistance Training in Older Inpatients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Keywords: Older adults
Strength training
Muscle mass
Function
Inpatients
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: St. James's Hospital, Ireland
First posted: 2014-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility study Randomised and controlled
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Lower limb dynamometry
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Functional mobility using the Timed Up and Go (TUG)
timeFrame: Baseline, Week 6
measure: Six Minute Walk Test (6MWT)
timeFrame: Baseline, Week 6
measure: EuroQol-5D (EQ-5D)
timeFrame: Baseline, Week 6
measure: Canadian Study of Health and Ageing Clinical Frailty Scale (CFS)
timeFrame: Baseline, Week 6
Other outcomes:
measure: Height and Weight and BMI
timeFrame: Baseline, Week 6
measure: Skeletal muscle mass
timeFrame: Baseline, Week 6
measure: Grip Strength
timeFrame: Baseline, Week 6
Locations:
city: Dublin
country: Ireland
facility: Physiotherapy Department, St James's Hospital, James's Street, Dublin 8, Ireland
Study officials:
affiliation: St James's Hospital, James's Street, Dublin 8, Ireland
name: Sinead Coleman, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal College of Surgeons in Ireland
name: Frances Horgan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St James's Hospital, James's Street, Dublin 8, Ireland
name: Niamh Murphy, MSc
role: STUDY_DIRECTOR
affiliation: St James's Hospital, James's Street, Dublin 8, Ireland
name: Gareth Clifford, MSc
role: STUDY_DIRECTOR
affiliation: St James's Hospital, James's Street, Dublin 8, Ireland
name: David Robinson, MD
role: STUDY_DIRECTOR
affiliation: St James's Hospital, James's Street, Dublin 8, Ireland
name: Conal Cunningham, MD
role: STUDY_DIRECTOR
References: