Thriving, Activity and Social Participation After Stroke
August 8, 2011 updated by: Ullevaal University Hospital
Well-being, Activity and Social Participation After Stroke/TIA. RCT-psycho Social Intervention Study.
The aim of the study is to evaluate the effect of a group intervention programme for community dwelling elders with stroke or TIA.The intervention is inspired by a Lifestyle Redesign method developed in the USA.
The study is conducted as a multi centre randomized controlled trial.
Participants are recruited from five hospitals and the intervention is implemented at six to seven senior centres.
The control group is offered physical activity at the senior centre once a week.
The intervention group is offered the same with addition of the programme inspired by Lifestyle Redesign.
The study will contribute to knowledge whether the intervention will promote social participation and thriving in daily life and prevent social isolation and depressive symptoms among community dwelling elders with stroke or TIA.
Study Overview
Status
Unknown
Conditions
Detailed Description
Stroke is a common disease among older people.
In Norway 60-70 000 people live with sequela after stroke.
Depressive symptoms, anxiety and social isolation are occurring among 20 to 60 percent.
Little is known about intervention for people with mild neurological symptoms who simultaneously perceive social isolation, depression and reduced satisfaction in their daily life after stroke.
Lifestyle redesign (LR) is developed in the USA and is a health promoting group intervention programme with focus on the participants' exchange of experiences and involvement.
The aim of the study is to evaluate the effect on thriving, activity and social participation of a group intervention program inspired by Lifestyle redesign for community dwelling persons with stroke.
The study is conducted as a multicentre randomized controlled trial.
Participants are recruited from five hospitals and the intervention is carried through at six to seven senior centres.
The control group is offered a physical activity programme at the senior centre once a week.
The intervention group is offered the same with the additional intervention programme also once a week.
The study will contribute to knowledge whether this group intervention will promote social participation and thriving in daily life and prevent social isolation and depressive symptoms among community dwelling elders with stroke or TIA.
Study Type
Interventional
Enrollment (Anticipated)
140
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oslo, Norway, 0407
- Ullevaal University Hospital, Department of Geriatric Medicine, Research Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- oral and written consent
- age 65+
- clinical stroke ref WHO definition
- home-dwelling previous to stroke
- home-service less than twice a week previous to stroke
- Barthel ADL-index >14 of 20
- MMS >23 of 30
- be able to communicate evaluated by Ulleval aphasia screening test
Exclusion Criteria:
- reduced consent
- severe disease
- clinical contradictions evaluated by the responsible physician
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 2
|
Group intervention inspired by Lifestyle Redesign
Other Names:
|
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EXPERIMENTAL: 1
|
Group intervention inspired by Lifestyle Redesign
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
SF-36
Time Frame: Approximately 3 months after stroke-BASELINE, after 6 and 9 months
|
Approximately 3 months after stroke-BASELINE, after 6 and 9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hospital Anxiety Depression Scale (HAD), Canadian Occupational Performance Measure (COPM), Trail making A and B, Timed up and go (TUG)
Time Frame: Approximately 3 months after stroke-BASELINE, after 6 and 9 months
|
Approximately 3 months after stroke-BASELINE, after 6 and 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Unni Sveen, PhD, Ullevaal University Hospital ,Medical division, research Unit 0407 Oslo Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (ACTUAL)
September 1, 2009
Study Completion (ANTICIPATED)
September 1, 2011
Study Registration Dates
First Submitted
July 2, 2007
First Submitted That Met QC Criteria
July 2, 2007
First Posted (ESTIMATE)
July 3, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
August 9, 2011
Last Update Submitted That Met QC Criteria
August 8, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UUS838
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.