NCT02141126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 12, 2021

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

January 6, 2014

Last Update Submit

March 9, 2021

Conditions

Muscle Weakness

Keywords

Older adultsStrength trainingMuscle massFunctionInpatients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Functional mobility using the Timed Up and Go (TUG)

    Baseline, Week 6

  • Six Minute Walk Test (6MWT)

    Baseline, Week 6

  • EuroQol-5D (EQ-5D)

    Baseline, Week 6

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

    Baseline, Week 6

Other Outcomes (3)

  • Height and Weight and BMI

    Baseline, Week 6

  • Skeletal muscle mass

    Baseline, Week 6

  • Grip Strength

    Baseline, Week 6

Study Arms (2)

Resistance training

EXPERIMENTAL

Usual care and resistance exercises.

Other: Resistance training

Usual care

OTHER

Usual inpatient physiotherapy

Other: Usual care

Interventions

Resistance trainingOTHER

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.

Resistance training
Usual careOTHER

Standard inpatient 'usual care' physiotherapy

Usual care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dublin, 8, Ireland

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sinead Coleman, MSc

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

    PRINCIPAL INVESTIGATOR

  • Frances Horgan, PhD

    Royal College of Surgeons in Ireland

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Feasibility study Randomised and controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

May 19, 2014

Study Start

July 1, 2013

Primary Completion

June 30, 2014

Study Completion

September 1, 2019

Last Updated

March 12, 2021

Record last verified: 2017-04

Locations

IE(1)