The effect of graded exercise and counselling with usual care plus a booklet for patients with fatigue in primary care

Completed

• Conditions: Fatigue; Signs and Symptoms; Malaise and fatigue

• Registration Number: ISRCTN72136156
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Age 16 to 75 years inclusive, either sex
2. Fatigue of 3 months or more
3. Patient presents fatigue as a main/important problem
4. Patient may have other physical problems, which in the doctor's judgement are unlikely to have caused their fatigue
5. Patient may be on stable drug regime for physical and/or psychological problems
6. Patient has had a normal full blood count, erythrocyte sedimentation rate (ESR) and thyroid function test during the six months prior to entering the study, or on entry to the study
7. Patient gives consent

Exclusion Criteria

1. A score of less than 4 on a fatigue scale
2. Patient has a physical condition/problem which does, or is likely to cause fatigue
3. Patient is suffering from psychotic illness, organic brain syndrome, or substance dependency
4. Patient is currently receiving treatment from a psychiatrist, counsellor, psychologist, Community Psychiatric Nurse (CPN), physiotherapist, or other exercise specialist
5. Patient is unable to come to the surgery for the treatment intervention
6. Patient has severe asthma, chronic obstructive airway disease and/or ischaemic heart disease that would contraindicate graded exercise

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue questionnaire, scored according to the Likert System (0, 1, 2, 3), from 4 to 33. It focuses measurement on the patients' self-reported symptom and has been tested for reliability and validity. Using this we have data from our own three studies, which include a cohort study and two trials, and data provided to us by other investigators. Binary scoring (0, 0, 1, 1) determines fatigue 'caseness', with a cut-off of 4 indicative of clinically significant fatigue. Patient's preference for treatment will be recorded at baseline.

Secondary Outcome Measures

Name	Time	Method
1. Anxiety and depression (Hospital Anxiety and Depression Scale [HADS])<br>2. Degree of functional impairment (Work and Social Adjustment Scale [WSAS]) (0 - 32)<br>3. Certified sickness absence<br>4. Illness attributions (physical = 1; psychological = 5)<br>5. Health-related quality of years using the EuroQol/EQ-5D instrument, which allows quality adjusted life years (QALYs) to be generated