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

ISRCTN	ISRCTN72136156
DOI	https://doi.org/10.1186/ISRCTN72136156
Protocol serial number	001; 068474
Sponsor	King's College London (UK)
Funder	The Wellcome Trust (UK) (grant ref: 068474)

Submission date: 13/10/2009
Registration date: 14/10/2009
Last edited: 20/12/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Leone Ridsdale
Scientific

Unit of Population Neurology
Department of Clinical Neuroscience
PO 41, Institute of Psychiatry
Camberwell
London
SE5 8AF
United Kingdom

Study information

Primary study design	Interventional
Study design	Pragmatic randomised controlled phase III trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	West Midlands multicentre research ethics committee (MREC) approved on the 3rd October 2002 (ref: MREC/01/7/71)
Health condition(s) or problem(s) studied	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
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.
Key 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
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	240
Key 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
Key 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
Date of first enrolment	01/10/2002
Date of final enrolment	31/03/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Unit of Population Neurology

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/08/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes