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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72136156
Enrollment
240
Registered
2009-10-14
Start date
2002-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue Signs and Symptoms Malaise and fatigue

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 durati

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026