Thriving, Activity and Social Participation After Stroke

NCT ID: NCT00495248

Last Updated: 2011-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Group intervention inspired by Lifestyle Redesign

Intervention Type BEHAVIORAL

Group intervention inspired by Lifestyle Redesign

Group intervention inspired by Lifestyle redesign

Intervention Type BEHAVIORAL

Lifestyle programme once a week for two hours over an intervention period of 9 months

2

Group Type ACTIVE_COMPARATOR

Group intervention inspired by Lifestyle Redesign

Intervention Type BEHAVIORAL

Group intervention inspired by Lifestyle Redesign

Interventions

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Group intervention inspired by Lifestyle Redesign

Group intervention inspired by Lifestyle Redesign

Intervention Type BEHAVIORAL

Group intervention inspired by Lifestyle redesign

Lifestyle programme once a week for two hours over an intervention period of 9 months

Intervention Type BEHAVIORAL

Other Intervention Names

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Lifestyle councelling

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Royal Norwegian Ministry of Health

OTHER

Sponsor Role collaborator

The Norwegian Women´s Public Health Association

OTHER

Sponsor Role collaborator

Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ullevaal University Hospital, Department of Geriatric Medicine

Principal Investigators

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Unni Sveen, PhD

Role: STUDY_DIRECTOR

Ullevaal University Hospital ,Medical division, research Unit 0407 Oslo Norway

Locations

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Ullevaal University Hospital, Department of Geriatric Medicine, Research Unit

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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UUS838

Identifier Type: -

Identifier Source: org_study_id

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