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The effect of graded exercise and counselling with usual care plus a booklet for patients with fatigue in primary care
DOI 10.1186/ISRCTN72136156
ClinicalTrials.gov identifier
EudraCT number
Public title The effect of graded exercise and counselling with usual care plus a booklet for patients with fatigue in primary care
Scientific title Graded exercise therapy and counselling versus a booklet provided with usual care in adult patients with fatigue in primary care: a pragmatic randomised controlled phase III trial
Acronym N/A
Serial number at source 001; 068474
Study hypothesis In the management of fatigue in primary care:
1. Graded exercise therapy (GET) will be significantly more effective than a booklet plus usual care (B+UC)
2. Counselling will be significantly more effective than a booklet plus usual care (B+UC)
Lay summary Not provided at time of registration
Ethics approval West Midlands multicentre research ethics committee (MREC) approved on the 3rd October 2002 (ref: MREC/01/7/71)
Study design Pragmatic randomised controlled phase III trial
Countries of recruitment United Kingdom
Disease/condition/study domain Fatigue
Participants - 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
Participants - 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
Anticipated start date 01/10/2002
Anticipated end date 31/03/2006
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 240 patients
Interventions Graded exercise patients will be shown how to take their own pulse, and home exercise will be prescribed on a gradually increasing basis up to a maximum of 30 minutes per day. The intensity and duration of this exercise and activity will be monitored using record sheets. The main exercise will be walking, with patients advised not to exceed the maximum prescribed each week (an instruction manual is available).

Counselling in general practice settings has generally taken the form of a non-directive, client-centred intervention, which is based on the theories of the American psychotherapist, Karl Rogers. The role of the counsellor is to encourage the client to express their feelings and thoughts about their situation, and to reflect on them and to come to their own decisions about themselves and the future (an instruction manual is available). Some sessions will be recorded, and therapy supervised by an independent exercise therapist.

Patients will have 8 sessions of treatment at two-week intervals followed by 2 telephone calls one month apart. To promote engagement the duration of the first assessment session will be approximately 60 minutes for all patients. After this, session length will be determined individually by each therapist and recorded.

Follow-up will be at 6 months and one year. The main outcome will be measured for all patients one year after recruitment to the study.
Primary outcome measure(s) 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 measure(s) 1. Anxiety and depression (Hospital Anxiety and Depression Scale [HADS])
2. Degree of functional impairment (Work and Social Adjustment Scale [WSAS]) (0 - 32)
3. Certified sickness absence
4. Illness attributions (physical = 1; psychological = 5)
5. Health-related quality of years using the EuroQol/EQ-5D instrument, which allows quality adjusted life years (QALYs) to be generated
Sources of funding The Wellcome Trust (UK) (grant ref: 068474)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22906319
Contact name Prof  Leone  Ridsdale
  Address Unit of Population Neurology
Department of Clinical Neuroscience
PO 41, Institute of Psychiatry
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
Sponsor King's College London (UK)
  Address c/o Sylvia Bediako
Research Grants Department
Institute of Psychiatry, P004
DeCrespigny Park
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Sponsor website: http://www.iop.kcl.ac.uk
Date applied 13/10/2009
Last edited 20/12/2012
Date ISRCTN assigned 14/10/2009
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