Thriving, Activity and Social Participation After Stroke - Full Text View

Purpose

The aim of the study is to evaluate the effect of a group intervention programme for community dwelling elders with stroke or TIA(Transischemic Attack. 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 I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:

SF-36 [ Time Frame: Approximately 3 months after stroke-BASELINE, after 6 and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Group intervention inspired by Lifestyle Redesign Group intervention inspired by Lifestyle Redesign Behavioral: Group intervention inspired by Lifestyle redesign Lifestyle programme once a week for two hours over an intervention period of 9 months
2: Active Comparator	Behavioral: Group intervention inspired by Lifestyle Redesign Group intervention inspired by Lifestyle Redesign

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

Criteria

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 Ullevaal aphasia screening test

Exclusion Criteria:

reduced consent
severe disease
clinical contradictions evaluated by the responsible physician

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495248

Contacts


Contact: Anne Lund, PhD student	+4722118718	Anne.Lund@hf.hio.no

Contact: Unni Sveen, PhD	+4723016155	Unni.Sveen@uus.no

Locations


Norway
	Ullevaal University Hospital, Department of Geriatric Medicine, Research Unit	Recruiting
	Oslo, Norway, 0407
	Contact: Anne Lund, Cand.san +4722118718 Anne.Lund@hf.hio.no
	Contact: Unni Sveen, Dr.Philos +4723016155 Unni.Sveen@uus.no
	Principal Investigator: Torgeir Bruun Wyller, Prof.

Sponsors and Collaborators

Ullevaal University Hospital

The Royal Norwegian Ministry of Health

The Norwegian womens` Health Association

Investigators


Study Director:	Unni Sveen, PhD	Ullevaal University Hospital ,Medical division, research Unit 0407 Oslo Norway

More Information

Responsible Party:	Ullevaal University Hospital, Department of Geriatric Medicine ( Unni Sveen - PhD )
Study ID Numbers:	UUS838
First Received:	July 2, 2007
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00495248
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Ullevaal University Hospital:

group intervention

stroke

senior centres

health promotion

Study placed in the following topic categories:

Cerebral Infarction

Stroke

Vascular Diseases

Central Nervous System Diseases

Brain Diseases

Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 06, 2008

Sponsors and Collaborators:	Ullevaal University Hospital The Royal Norwegian Ministry of Health The Norwegian womens` Health Association
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00495248