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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness
• Intervention / Treatment: Other: Resistance training; Other: Usual care

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 8
    • Physiotherapy Department, St James's Hospital, James's Street, Dublin 8, Ireland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance training; Usual care and resistance exercises.	Other: Resistance 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.
Other: Usual care; Usual inpatient physiotherapy	Other: Usual care; Standard inpatient 'usual care' physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	Baseline, Week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height and Weight and BMI	Height 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.	Baseline, Week 6
Skeletal muscle mass	Skeletal muscle mass will be calculated using a validated equation based on measured bioimpedance from the body composition scales (Janssen J Appl Phil 2000).	Baseline, Week 6
Grip Strength	Grip strength will be measured using a handgrip dynamometer on the non-dominant arm (Clinifeed/Roussel dynamometer).	Baseline, Week 6

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Collaborators: St. James's Hospital, Ireland
• Investigators: Principal Investigator: Sinead Coleman, MSc, St James's Hospital, James's Street, Dublin 8, Ireland; Principal Investigator: Frances Horgan, PhD, Royal College of Surgeons in Ireland; Study Director: Niamh Murphy, MSc, St James's Hospital, James's Street, Dublin 8, Ireland; Study Director: Gareth Clifford, MSc, St James's Hospital, James's Street, Dublin 8, Ireland; Study Director: David Robinson, MD, St James's Hospital, James's Street, Dublin 8, Ireland; Study Director: Conal Cunningham, MD, St James's Hospital, James's Street, Dublin 8, Ireland

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): June 30, 2014
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 19, 2014

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Older adults; Function; Inpatients; Muscle mass; Strength training
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: RCSI-SJH; RCSI-SJH-MISA (Other Identifier: RCSI-SJH-MISA); RCSI-SJH-MISA-2013 (Other Identifier: RCSI-SJH-MISA-2013)