ANZCTR - Registration

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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

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A 10 week, community-based progressive resistance training (PRT) program.

Intervention code [1]

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]

To test whether a PRT program for poststroke depression will result in a reduction in depressive symptoms, measured using the CES-D.

Timepoint [1]

Assessments will be conducted at baseline, ten weeks and six months.

Secondary outcome [1]

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]

Objective measures will be assessed at assessments will occur at baseline and 10 weeks.

Secondary outcome [2]

Self report assessments

Timepoint [2]

At baseline, 10 weeks and six months.

Secondary outcome [3]

Muscle strength will be assessed from the 1 repetition maximum (1-RM) for upper and lower limbs.

Timepoint [3]

Objective measures will be assessed at assessments will occur at baseline and 10 weeks.

Secondary outcome [4]

Gait testing will be also conducted, by a physiotherapist.

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Beyond Blue

Address [1]

PO Box 6100
Hawthorn West
VICTORIA 3122

Country [1]

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]

None

Name [1]

n/a

Address [1]

Country [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Jane Sims

Address

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

Australia

Phone

+61 3 9501 2436

Fax

+61 3 8575 2233

j.sims@unimelb.edu.au

Contact person for scientific queries

Name

Dr Jane Sims

Address

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

Australia

Phone

+61 3 9501 2436

Fax

+61 3 8575 2233

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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