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Lower Limb Resistance Training in Older Inpatients

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Resistance training
Usual care
Sponsored by
Royal College of Surgeons, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring Older adults, Strength training, Muscle mass, Function, Inpatients

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Resistance training

Usual care

Arm Description

Usual care and resistance exercises.

Usual inpatient physiotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
January 6, 2014
Last Updated
March 9, 2021
Sponsor
Royal College of Surgeons, Ireland
Collaborators
St. James's Hospital, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT02141126
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
June 30, 2014 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal College of Surgeons, Ireland
Collaborators
St. James's Hospital, Ireland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
Older adults, Strength training, Muscle mass, Function, Inpatients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Feasibility study Randomised and controlled
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance training
Arm Type
Experimental
Arm Description
Usual care and resistance exercises.
Arm Title
Usual care
Arm Type
Other
Arm Description
Usual inpatient physiotherapy
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Standard inpatient 'usual care' physiotherapy
Primary Outcome Measure Information:
Title
Lower limb dynamometry
Description
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.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Functional mobility using the Timed Up and Go (TUG)
Description
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.
Time Frame
Baseline, Week 6
Title
Six Minute Walk Test (6MWT)
Description
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.
Time Frame
Baseline, Week 6
Title
EuroQol-5D (EQ-5D)
Description
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.
Time Frame
Baseline, Week 6
Title
Canadian Study of Health and Ageing Clinical Frailty Scale (CFS)
Description
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).
Time Frame
Baseline, Week 6
Other Pre-specified Outcome Measures:
Title
Height and Weight and BMI
Description
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.
Time Frame
Baseline, Week 6
Title
Skeletal muscle mass
Description
Skeletal muscle mass will be calculated using a validated equation based on measured bioimpedance from the body composition scales (Janssen J Appl Phil 2000).
Time Frame
Baseline, Week 6
Title
Grip Strength
Description
Grip strength will be measured using a handgrip dynamometer on the non-dominant arm (Clinifeed/Roussel dynamometer).
Time Frame
Baseline, Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinead Coleman, MSc
Organizational Affiliation
St James's Hospital, James's Street, Dublin 8, Ireland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frances Horgan, PhD
Organizational Affiliation
Royal College of Surgeons in Ireland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niamh Murphy, MSc
Organizational Affiliation
St James's Hospital, James's Street, Dublin 8, Ireland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gareth Clifford, MSc
Organizational Affiliation
St James's Hospital, James's Street, Dublin 8, Ireland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Robinson, MD
Organizational Affiliation
St James's Hospital, James's Street, Dublin 8, Ireland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Conal Cunningham, MD
Organizational Affiliation
St James's Hospital, James's Street, Dublin 8, Ireland
Official's Role
Study Director
Facility Information:
Facility Name
Physiotherapy Department, St James's Hospital, James's Street, Dublin 8, Ireland
City
Dublin
ZIP/Postal Code
8
Country
Ireland

12. IPD Sharing Statement

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Lower Limb Resistance Training in Older Inpatients

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