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Completed

NCT Number: NCT02141126

Lower Limb Resistance Training in Older Inpatients

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.

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Key information

Conditions

Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Dublin, 8, Ireland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistance training

Other

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 Care

Other

Standard inpatient 'usual care' physiotherapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functional mobility using the Timed Up and Go (TUG)

    Time frame: Baseline, Week 6

    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.

  2. Six Minute Walk Test (6MWT)

    Time frame: Baseline, Week 6

    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.

  3. EuroQol-5D (EQ-5D)

    Time frame: Baseline, Week 6

    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.

  4. Canadian Study of Health and Ageing Clinical Frailty Scale (CFS)

    Time frame: Baseline, Week 6

    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).

Other outcomes

  1. Height and Weight and BMI

    Time frame: Baseline, Week 6

    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.

  2. Skeletal muscle mass

    Time frame: Baseline, Week 6

    Skeletal muscle mass will be calculated using a validated equation based on measured bioimpedance from the body composition scales (Janssen J Appl Phil 2000).

  3. Grip Strength

    Time frame: Baseline, Week 6

    Grip strength will be measured using a handgrip dynamometer on the non-dominant arm (Clinifeed/Roussel dynamometer).

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Collaborators

  • St. James's Hospital, Ireland

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2019
First posted
May 19, 2014
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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