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 |
| Secondary identifying numbers | 001; 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
Scientific
Unit of Population Neurology
Department of Clinical Neuroscience
PO 41, Institute of Psychiatry
Camberwell
London
SE5 8AF
United Kingdom
Study information
| Study design | Pragmatic randomised controlled phase III trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/10/2002 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 240 patients |
| 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
- England
- United Kingdom
Study participating centre
Unit of Population Neurology
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
c/o Sylvia Bediako
Research Grants Department
Institute of Psychiatry, P004
DeCrespigny Park
London
SE5 8AF
England
United Kingdom
| Website | http://www.iop.kcl.ac.uk |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 068474)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
