NCT00107068

Brief Summary

This study will investigate the efficacy of aerobic exercise and progressive resistance training (PRT), singularly and combined, on changes in walking endurance for mildly-to-moderately affected chronic stroke patients. Specifically, we will determine the relative importance of training induced changes in muscle strength versus aerobic fitness on increases in gait velocity and 6-min walking distance, and assess the concomitant functional and psychosocial impact of increased muscle strength, aerobic fitness and improved gait. This longitudinal study will be conducted as a double blinded factorial randomized controlled trial of exercise training for chronic stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable stroke

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

January 1, 2001

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2005

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

2.2 years

First QC Date

April 4, 2005

Last Update Submit

December 2, 2015

Conditions

Stroke

Keywords

StrokeExerciseAerobicPRTWalking ability

Outcome Measures

Primary Outcomes (1)

  • Subjects will undertake a 6 min walking test for maximum distance

Secondary Outcomes (4)

  • Cardiorespiratory Fitness

  • Lower limb muscular strength and endurance

  • Mobility variables

  • Scales and questionnaires

Interventions

[A] Aerobic isokinetic cycling exercisePROCEDURE
[B] Progressive Resistance TrainingPROCEDURE
[A] + [B]PROCEDURE

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 45 years
  • First stroke resulting in hemiplegia
  • At least 4-months post stroke
  • Residing at home or community-based (non-institutionalized) living environment
  • Self selected gait velocity between 0.42 m/s to 0.80 m/s
  • No longer receiving physiotherapy.
  • Adequate comprehension of instructions and perceptual abilities (assessed by stroke clinician during medical screening), no significant musculotendinous or bony restrictions of the affected limb, nor any serious chronic disease independently causing significant disability or profound atrophy of the affected limb will comprise further indications to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Research Centre, University of Sydney

Sydney, New South Wales, 2141, Australia

Location

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2005

First Posted

April 5, 2005

Study Start

January 1, 2001

Primary Completion

March 1, 2003

Study Completion

May 1, 2004

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

AU(1)