Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001; 068474
Study information
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
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)
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Fatigue
Intervention
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.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
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
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
Overall trial start date
01/10/2002
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240 patients
Participant 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
Recruitment start date
01/10/2002
Recruitment end date
31/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Unit of Population Neurology
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
c/o Sylvia Bediako
Research Grants Department
Institute of Psychiatry
P004
DeCrespigny Park
London
SE5 8AF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 068474)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22906319
Publication citations
-
Results
Sabes-Figuera R, McCrone P, Hurley M, King M, Donaldson AN, Ridsdale L, Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care., BMC Health Serv Res, 2012, 12, 264, doi: 10.1186/1472-6963-12-264.