Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Stroke
• Interventions: Behavioral: Health promotion program

• Registration Number: NCT01629654
• Lead Sponsor: University of Aarhus

Brief Summary

Fatigue is a common complaint after stroke, reported by 39-72% of patients. Poststroke fatigue is related to poor neurological recovery, low level of activities of daily living, decreased quality of life and may possibly affect the ability to return to work. Little is known about strategies addressing post-stroke fatigue and their effectiveness.

Aim: to develop, test and evaluate a health promotion program based on strategies addressing poststroke fatigue.

Detailed Description

Fatigue is a common complaint after stroke, reported by 39-72% of patients. It has been shown that poststroke fatigue may be related to poor neurological recovery, low level of activities of daily living and decreased quality of life. However, little is known about strategies to address poststroke fatigue and the effectiveness of such strategies.

Objective The aim of the study is to develop a program based on strategies to address poststroke fatigue and to test and evaluate the program.

Material and Methods Intervention Mapping is the overall approach of the study. It describes a protocol for the development of theory- and evidence-based health promotion programmes.

Step 1) The program is developed based on a needs assessment. Existing knowledge about physical, psychosocial and environmental factors associated with poststroke fatigue is mapped in a literature review.

Step 2) The program will be tested in a pilot study (controlled trial). In addition to conventional treatment, the patients in the intervention group will participate in the program for a period of 12 weeks. The control group will receive conventional treatment only.

Step 3) Evaluation of the program: Primary outcome measure will be fatigue, measured on the Multidimensional Fatigue Inventory-20. Secondary outcome measures will be identified during the development of the program. Patients will be tested at baseline, after 3 months and after 6 months. The effect size in the pilot study will be assessed and will be used in order to estimate the required sample size for a large-scale randomized controlled trial on formally testing the efficacy of the program.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-01-20
• Primary Completion: 2012-03
• Status Verified: 2012-06
• Study Completion: 2012-06
• Study First Submitted QC: 2012-06-25
• Last Update Submitted: 2012-06-25
• Study First Posted: 2012-06-27
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Patients with first ever stroke
• > 18 year
• Living in the area of Aarhus(intervention group) and patients living in the area of Holstebro (control group).
• Multidimensional Fatigue Inventory-20/Generel Fatigue > 12.
• The patient must be able to give informed consent
• Walking without person support.
• Walking aids is accepted.

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Exclusion Criteria

• Neurological problems related to acute stroke(severe aphasia, decreased level of conscience or decreased attention)
• Other neurologic or psychiatric deseases (including dementia, non treated depression, misuse of alcohol eller medicin)
• Severe co-morbidity (including cancer, blindness or deathness)
• Not-danish speaking.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Health promotion program	Testing of the teory- and evidence based health promotion program. Patients will participate in a 13 weeks program.

Primary Outcome Measures

Name	Time	Method
Multidimensional Fatigue Inventory 20	Change from baseline in MFI-20 at 3 and 6 months	The multidimensional Fatigue Inventory 20 is a multidimensional fatigue score covering five dimensions of fatigue: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Activity. Pathologic Fatigue is defined as a score ≥ 12 on the General Fatigue dimension.

Secondary Outcome Measures

Name	Time	Method
The general self-efficacy scale	Change from baseline in the generel self-efficacy scale at 3 and 6 months	The general self-efficacy scale is a scale measuring how individuals cope with distressing situations

Trial Locations

Locations (1)

Department of Neurology, Aarhus University Hospital; 🇩🇰 Aarhus, Central Denmark Region, Denmark