Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Leone Ridsdale

ORCID ID

Contact details

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

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

http://www.iop.kcl.ac.uk

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

  1. 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.

Editorial Notes