The effect of a 10 week exercise intervention on cancer related fatigue in cancer survivor’s with documented fatigue compared to a 10 week health education programme

• Register: ISRCTN
• Last refreshed on: 24 October 2022
• Main ID: ISRCTN58635908
• Date of registration: 08/06/2017
• Prospective Registration: No
• Primary sponsor: Waterford Institute of Technology
• Public title: The effect of a 10 week exercise intervention on cancer related fatigue in cancer survivor’s with documented fatigue compared to a 10 week health education programme
• Scientific title: Evaluation of a Sustainable Intervention using Exercise - for Cancer Fatigue (ESIE-CF Trial)
• Date of first enrolment: 26/06/2015
• Target sample size: 50
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN58635908
• Study type: Interventional
• Study design: Interventional non randomised multi-centre cross over study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Ireland

Contacts

• Name: Patricia Sheehan

Key inclusion & exclusion criteria

Inclusion criteria:
1. Women and men
2. Aged 18 or older
3. Breast, colorectal and prostate cancer survivors
4. At least 6 weeks but not more than 10 years following the completion of surgery, radiotherapy and chemotherapy (to allow for stabilisation of fatigue following treatment) but not excluding those on ongoing hormonal therapy
5. Ongoing fatigue (FACT-F score <45) (the lower the score the higher the fatigue)
6. Currently undertaking less than 90 min or more of moderate intensity exercise weekly

Exclusion criteria:
1. Inability to travel for testing and to group exercise/health education sites
2. GP unwilling to provide medical clearance for moderate intensity exercise
3. Orthopaedic limitations that render participant unable to participate in a class-based moderate intensity exercise programme
4. Currently undertaking 90 min or more of moderate intensity exercise weekly


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer related fatigue in post treatment cancer survivors
Cancer
Cancer related fatigue in post treatment cancer survivors

Intervention(s)

This study is a quasi-experimental multi centre trial. A repeated measures design is being used comparing a ten week semi-supervised progressive exercise intervention to a non-exercise health education comparison condition, with crossover from the comparison (health education) to the exercise arm of the study at the end of the comparison period. Those who express interest are either sent or given an information letter. After providing written informed consent, participants obtain medical clearance from their general practitioner and complete baseline assessments. Participants are allocated to either the non-exercise health education or the progressive arm consecutively.

Arm 1: Exercisers meet twice per week (p/w) for the first five weeks reducing to once p/w for the remaining five weeks to enable sustainability of exercise on intervention completion. Classes are one-hour sessions and can include brisk walking, indoor circuits, flexibility and mobility. The classes include progressive aerobic exercise (both in volume and intensity) starting with low-moderate intensity. Exercise principally group based and supervised though allowing for individual differences in fitness and energy levels. Some home-based, potentially buddied activity included as intervention progresses. They include a combination of walking and indoor exercise classes as primary exercise mode. Walking sessions can include some interval work towards end of intervention to increase intensity intermittently as needed to ensure progression

Arm 2: The health education group meet once per week for ten weeks. One-hour sessions focus on strategies other than exercise to manage fatigue, such as food and nutrition, cognitive behaviour therapy and sleep management.

Primary Outcome(s)

Fatigue is measured using the FACT-F measured at baseline, week four, week eight, post intervention and at six month follow up.

Secondary Outcome(s)

1. Quality of life is measured using Quality of life (EORTC) questionnaire at baseline, post intervention, and at six month follow up
2. Fear of Physical Activity among breast cancer survivors is measured using Fear of Physical Activity and Exercise in Survivors of Breast Cancer questionnaire at baseline, post intervention, and at six month follow up
3. Sleep difficulties are measured using Insomnia Severity Index at post intervention, and at six month follow up
4. Self-efficacy in general health management is measured using the Perceived Health Competency questionnaire at baseline, post intervention, and at six month follow up
5. Fitness is measured using the six minute walk/run test, handgrip dynamometer, sit to stand test, sit & reach test and the one legged balance test at baseline, post intervention, and at six month follow up
6. Vascular function is measured using the arterial stiffness via pulse wave velocity at baseline, post intervention, and at six month follow up
7. Body weight, height and blood pressure are measured at baseline, post intervention, and at six month follow up
8. Physical activity levels are measured using the International Physical Activity Questionnaire (IPAQ) at baseline, post intervention, and at six month follow up
9. Salivary cortisol are measured using saliva samples at baseline and post intervention
10. Cytokines are measured using blood samples at baseline, post intervention, and at six month follow up

Secondary ID(s)

1725

Source(s) of Monetary Support

Waterford Institute of Technology

Ethics review

Status:
Approval date:
Contact:

Waterford Institute of Technology, The Health Service Executive South East and University Hospital Waterford, 10/06/2015

Results

• Date Completed: 01/12/2017