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Regenerate: a strength-training program to enhance the physical and mental health of chronic post stroke patients with depression

Regenerate: a strength-training program to enhance the physical and mental health of chronic post stroke patients with depression

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000613606
Enrollment
60
Registered
2005-10-07
Start date
2005-10-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Sponsors

The University of Melbourne, School of Physiotherapy
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Community dwelling stroke patients, chronic cases (6-12 months post first stroke).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026