Lower Limb Resistance Training in Older Inpatients

NCT ID: NCT02141126

Last Updated: 2021-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-01

Study Completion Date

2019-09-01

Brief Summary

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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

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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

Conditions

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Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Feasibility study Randomised and controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Resistance training

Usual care and resistance exercises.

Group Type EXPERIMENTAL

Resistance training

Intervention Type 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

Usual inpatient physiotherapy

Group Type OTHER

Usual care

Intervention Type OTHER

Standard inpatient 'usual care' physiotherapy

Interventions

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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.

Intervention Type OTHER

Usual care

Standard inpatient 'usual care' physiotherapy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. James's Hospital, Ireland

OTHER

Sponsor Role collaborator

Royal College of Surgeons, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sinead Coleman, MSc

Role: PRINCIPAL_INVESTIGATOR

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

Frances Horgan, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal College of Surgeons in Ireland

Niamh Murphy, MSc

Role: STUDY_DIRECTOR

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

Gareth Clifford, MSc

Role: STUDY_DIRECTOR

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

David Robinson, MD

Role: STUDY_DIRECTOR

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

Conal Cunningham, MD

Role: STUDY_DIRECTOR

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

Locations

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

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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RCSI-SJH-MISA

Identifier Type: OTHER

Identifier Source: secondary_id

RCSI-SJH-MISA-2013

Identifier Type: OTHER

Identifier Source: secondary_id

RCSI-SJH

Identifier Type: -

Identifier Source: org_study_id

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