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A study to evaluate the effect of a home-based exercise programme to manage cancer-related fatigue and improve quality of life for women recently diagnosed with gynaecological cancer

A randomised, single blind, controlled trial to evaluate the safety and efficacy of a home-based exercise programme to manage cancer-related fatigue for women recently diagnosed with gynaecological cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93279771
Enrollment
60
Registered
2008-07-25
Start date
2008-04-07
Completion date
Unknown
Last updated
2017-10-30

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

Conditions

Gynaecological cancer Cancer Gynaecological cancer

Interventions

1. Exercise group (usual care plus home-based exercise programme): Participants randomised to this group will be facilitated to participate in a moderate home-based exercise programme during the cours

Sponsors

University of Ulster (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged 18 years old or over 2. Recently diagnosed with stages 0 - III gynaecological cancer 3. Completed surgery and are currently receiving radiotherapy or chemotherapy or have completed anti-cancer treatment and are less than one year post anti-cancer treatment 4. Reporting mild, moderate or severe fatigue based on a numeric rating scale (where 0 = no fatigue and 10 = worst fatigue you can imagine) 5. Currently sedentary (exercising less than once a week for 20 minutes at a vigorous intensity or less than two times per week for 30 minutes at moderate intensity or less than 20 minutes three times per week, for the past six months) 6. Ambulatory and without use of a walking aid 7. Willing to be randomised

Exclusion criteria

Exclusion criteria: 1. Have any medical or current psychiatric illness that could make compliance with the study protocol difficult or dangerous (e.g., unstable cardiovascular disease, hypertension, diabetes, respiratory disease, severe mental illness, cognitive dysfunction or orthopaedic problems that would limit exercise training) 2. Previously diagnosed with a fatigue-related co-morbid medical condition (fibromyalgia, chronic fatigue syndrome, multiple sclerosis (MS), myalgic encephalopathy (ME), lupus or arthritis) 3. History of cancer, i.e., not treatment naive 4. Participating in other intervention trials

Design outcomes

Primary

MeasureTime frame
Fatigue: the Multi-dimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) and Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F). Outcome measures will be taken at four timepoints including, baseline, 6 weeks, 12 weeks and 3 months post-intervention.

Secondary

MeasureTime frame
1. Quality of life: Functional Assessment of Cancer Therapy - General (FACT-G) 2. Cardiorespiratory fitness: 12-minute walk test 3. Physical activity questionnaire: Seven- Day Physical Activity Recall (7-Day PAR) 4. Stage of motivational readiness for PA 5. Self-efficacy to exercise: Self-Efficacy Scale 6. Decisional balance for PA 7. Processes of change for PA 8. Mood: Positive And Negative Affects Scale (PANAS) 9. Sleep hygiene: Pittsburgh Sleep Disturbance Scale 10. Depression: Beck Depression Inventory 11. Functional assessment: timed sit to stand Outcome measures will be taken at four timepoints including, baseline, 6 weeks, 12 weeks and 3 months post-intervention.

Countries

United Kingdom

Outcome results

None listed

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