Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000613606
Ethics application status
Approved
Date submitted
3/10/2005
Date registered
7/10/2005
Date last updated
5/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Regenerate: a strength-training program to enhance the physical and mental health of chronic post stroke patients with depression
Scientific title
Regenerate: a strength-training program to enhance the physical and mental health of chronic post stroke patients with depression
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic post stroke 745 0
Condition category
Condition code
Stroke 821 821 0 0
Ischaemic
Stroke 2723 2723 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 10 week, community-based progressive resistance training (PRT) program.
Intervention code [1] 692 0
Rehabilitation
Comparator / control treatment
Wait list control until end of 6 month follow-up period. Participants were then sent a copy of the findings and were free to do the program if they wished.
Control group
Active

Outcomes
Primary outcome [1] 1053 0
To test whether a PRT program for poststroke depression will result in a reduction in depressive symptoms, measured using the CES-D.
Timepoint [1] 1053 0
Assessments will be conducted at baseline, ten weeks and six months.
Secondary outcome [1] 1958 0
The secondary outcome measures are health and wellbeing status. These will be measured using the SF-12; Human Activities Profile (HAP), Australian Quality of Life (AQOL); Social Support; Self-Esteem; Recovery Locus of Causality Scales.
Timepoint [1] 1958 0
Objective measures will be assessed at assessments will occur at baseline and 10 weeks.
Secondary outcome [2] 1959 0
Self report assessments
Timepoint [2] 1959 0
At baseline, 10 weeks and six months.
Secondary outcome [3] 1960 0
Muscle strength will be assessed from the 1 repetition maximum (1-RM) for upper and lower limbs.
Timepoint [3] 1960 0
Objective measures will be assessed at assessments will occur at baseline and 10 weeks.
Secondary outcome [4] 1961 0
Gait testing will be also conducted, by a physiotherapist.
Timepoint [4] 1961 0
Objective measures will be assessed at assessments will occur at baseline and 10 weeks.

Eligibility
Key inclusion criteria
Community dwelling stroke patients, chronic cases (6-12 months post first stroke).
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those scoring below 5 on the Patient Health Questionnaire (PHQ-9) and those clinically unsuitable (depression with psychotic features; schizophrenia; bipolar disorder; suicidal ideation; dementia; terminally ill; uncontrolled hypertension (SBP>210, DBP> 110), unstable insulin dependent diabetes (two or more hypoglycaemic episodes in the previous 3 months); unstable angina; other psychiatric diagnoses; alcohol or drug related depression) and those unable to ambulate a distance of at least 20m independently or with the assistance of a gait assistive device.

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)
Central telephone. Concealed until intervention is assigned
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomised lists, stratified for gender
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
A wait list control group will be offered the intervention at the end of the study
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 909 0
Charities/Societies/Foundations
Name [1] 909 0
Beyond Blue
Country [1] 909 0
Australia
Primary sponsor type
University
Name
The University of Melbourne, School of Physiotherapy
Address
200 Berkeley Street,
Carlton 3053
Country
Australia
Secondary sponsor category [1] 768 0
None
Name [1] 768 0
n/a
Address [1] 768 0
Country [1] 768 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This project is a randomised controlled trial (RCT) of an exercise intervention aimed at reducing depression amongst chronic stroke sufferers. This study will include a progressive resistance training (PRT) program, i.e., exercising with weights for people who had a stroke within the last six to twelve months. Participants, 18 years of age and over, will be recruited via stroke centres such as the Royal Talbot Rehabilitation Centre, general practices and stroke support groups, and through a media campaign using local newspapers and pamphlets in community venues.
People interested in participating will receive participant information and consent form and a brief survey to determine whether they meet the eligibility criteria to participate.
Those who meet the threshold for depressive symptoms will undergo an assessment by a psychiatrist, to confirm their mental health status. A project officer will then help them to complete several surveys to determine their current health status. The assessment will take up to two hours and take place at central location with easy access. Participants will have a 50:50 chance of being allocated to attend the PRT program or to be placed on a waiting list. The PRT is suitable for older people who have never done this type of exercise. The program will consist of two one hour sessions per week for ten weeks. The program will be conducted at the YMCA's Hawthorn Aquatic and Leisure Centre, facilitated by staff qualified in exercise supervision for older people. Where necessary, these staff will upskill similar staff at other venues to provide the program, using a standardised protocol. Participants will follow a standardised program of upper and lower limb exercises, tailored according to their abilities. They will pay $5 per session to attend. Assistance with transport will be provided where required. At the end of the ten week program all participants will undertake a follow-up assessment. They will be mailed copies of the surveys from the initial assessment for completion. Another follow-up will occur at six months. This will enable the impact of the exercise upon health status, in particular depression, to be determined. It is anticipated that the intervention will provide chronic stroke patients with depression not only amelioration of their depression, but also improved health and the ability to do daily tasks. It is hoped that the group's level of independence will be improved or maintained. Some may choose to continue to exercise in mainstream community exercise programs to help prevent future health problems.
Those who do not meet the threshold for depressive symptoms will be invited to complete the health surveys at three time points (baseline, 10 weeks, 6 months). This will enable us to assess the recovery process over time in those with and without depression. The data will allow us to examine characteristics of the person that influence their recovery path.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35268 0
Address 35268 0
Country 35268 0
Phone 35268 0
Fax 35268 0
Email 35268 0
Contact person for public queries
Name 9881 0
Dr Jane Sims
Address 9881 0
Senior Research Fellow
Healthy Ageing Research Unit
Monash University
Primary Care Research
Building 1 (Rm 29)
270 Ferntree Gully Rd
Notting Hill
VICTORIA 3168
Country 9881 0
Australia
Phone 9881 0
+61 3 9501 2436
Fax 9881 0
+61 3 8575 2233
Email 9881 0
j.sims@unimelb.edu.au
Contact person for scientific queries
Name 809 0
Dr Jane Sims
Address 809 0
Senior Research Fellow
Healthy Ageing Research Unit
Monash University
Primary Care Research
Building 1 (Rm 29)
270 Ferntree Gully Rd
Notting Hill
VICTORIA 3168
Country 809 0
Australia
Phone 809 0
+61 3 9501 2436
Fax 809 0
+61 3 8575 2233
Email 809 0
Jane.Sims@med.monash.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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