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Completed

NCT Number: NCT01629654

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Health Promotion Program

Behavioral

A 13 weeks organized program:

  • One group session about poststroke fatigue involving both patient and relatives
  • Two personal meetings, involving both patient and relatives
  • Three telephone meetings, involving only patient

Other names: Poststroke fatigue, Complex interventions

Primary outcomes

  1. Multidimensional Fatigue Inventory 20

    Time frame: 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 outcomes

  1. The general self-efficacy scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Aase and Ejnar Danielsens Foundation
  • The Novo Nordic Foundation

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2012
Registry last updated
Jun 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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