Thriving, Activity and Social Participation After Stroke
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Behavioral: Group intervention inspired by Lifestyle Redesign Behavioral: Group intervention inspired by Lifestyle redesign |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Well-being, Activity and Social Participation After Stroke/TIA. RCT-psycho Social Intervention Study. |
- SF-36 [ Time Frame: Approximately 3 months after stroke-BASELINE, after 6 and 9 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Behavioral: Group intervention inspired by Lifestyle Redesign
Group intervention inspired by Lifestyle Redesign
Other Name: Lifestyle councelling
Behavioral: Group intervention inspired by Lifestyle redesign
Lifestyle programme once a week for two hours over an intervention period of 9 months
|
| Active Comparator: 2 |
Behavioral: Group intervention inspired by Lifestyle Redesign
Group intervention inspired by Lifestyle Redesign
Other Name: Lifestyle councelling
|
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Norway | |
| Ullevaal University Hospital, Department of Geriatric Medicine, Research Unit | |
| Oslo, Norway, 0407 | |
| Study Director: | Unni Sveen, PhD | Ullevaal University Hospital ,Medical division, research Unit 0407 Oslo Norway |
More Information
No publications provided
| Responsible Party: | Unni Sveen - PhD, Ullevaal University Hospital, Department of Geriatric Medicine |
| ClinicalTrials.gov Identifier: | NCT00495248 History of Changes |
| Other Study ID Numbers: | UUS838 |
| Study First Received: | July 2, 2007 |
| Last Updated: | August 8, 2011 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Oslo University Hospital:
|
group intervention stroke senior centres health promotion |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 22, 2013