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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00107068




Registration number
NCT00107068
Ethics application status
Date submitted
4/04/2005
Date registered
5/04/2005
Date last updated
3/12/2015

Titles & IDs
Public title
Exercise Training and Walking Ability After Chronic Stroke
Scientific title
Does Aerobic or Resistance Exercise Training Improve Walking Ability in Chronic Stroke Patients?
Secondary ID [1] 0 0
NHMRC 153970
Secondary ID [2] 0 0
NHMRC 153970
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subjects will undertake a 6 min walking test for maximum distance
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Cardiorespiratory Fitness
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Lower limb muscular strength and endurance
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Mobility variables
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Scales and questionnaires
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
* 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
Minimum age
45 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects will be excluded if they have significant cardiac disease, symptom limiting peripheral vascular disease, or any of the exclusion criteria contraindicating moderate exercise as outlined by the American College of Sports Medicine guidelines for cardiac disease rehabilitation or for frail and elderly adults. The initial symptom-limited/maximal aerobic assessment will serve as the screening test for contraindications to further exercise.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2004
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Rehabilitation Research Centre, University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2141 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00107068
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00107068