Evaluation of a community based exercise program for people with cancer

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001669482
• Date of registration: 05/12/2016
• Prospective Registration: No
• Primary sponsor: Edith Cowan University
• Public title: Evaluation of a community based exercise program for people with cancer
• Scientific title: Effect of a community based exercise program on quality of life for people with cancer
• Date of first enrolment: 01/01/2011
• Target sample size: 600
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001669482.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: A/Prof Prue Cormie

• Name: A/Prof Prue Cormie

Key inclusion & exclusion criteria

Inclusion criteria: 1) People with any diagnosis of cancer who are currently receiving treatment or within two years of completing treatment for cancer
2) Physician consent
Exclusion criteria: 1) Neutropenia; 2) severe anaemia; 3) bone metastases; or 4) any musculoskeletal, cardiovascular or neurological disorder that could place the participant at risk of injury or illness resulting from the exercise program (as determined by the patient’s physician).

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Any cancer

Cancer;
Cancer

Intervention(s)

The Cancer Council WA Life Now Exercise program intervention consists of a pre- and post- program individual exercise physiologist consultation and 3 months of twice weekly group-based exercise sessions administered in community exercise clinics under the supervision of exercise physiologists specifically trained to deliver the Life Now Exercise program. The twice weekly exercise sessions are conducted in groups of approximately 10 participants under the supervision of an accredited exercise physiologist. The maximum number of participants per group is 15-20 (site dependent) and the groups are administered with an exercise physiologist to participant ratio of up to 1:10. The sessions last approximately 1 hour in duration and consist of a combination of moderate to high intensity aerobic and resistance exercise as well as flexibility exercises. The aerobic exercise component includes 20 to 30 minutes of at least moderate intensity cardiovascular exercise using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. The target intensity is between 60 to 85% of estimated heart rate maximum. The resistance exercise component involves 6 to 10 exercises that target the major upper and lower body muscle groups. Target intensity is manipulated from 6-12 repetition maximum (RM; i.e. the maximal weight that can be lifted 6 to 12 times which is equivalent to ~60-85% of 1RM) using 1-4 sets per exercise. Resistance exercise selection is individually prescribed. The flexibility component involves approximately 5 minutes of stretching of the major muscle groups for 15-30 second duration each. Exercise prescription is progressive and modified according to individual response. Session ratings of perceived exertion (RPE) are recorded aft

Primary Outcome(s)

Health-related quality of life determined by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
[Baseline (0 months) and post-intervention (3 months)
]

Secondary Outcome(s)

Self-reported exercise levels determined by the Godin Leisure-Time Exercise Questionnaire (modified to include participation in resistance exercise)[Baseline (0 months) and post-intervention (3 months)]

Uptake determined by participation rate and number of patients who register but do not commence participation in the program[Throughout the intervention]

Exercise motivation derived from the Theory of Planned Behaviour and determined by using validated questionnaires (theory of planned behaviour exercise motivation survey)[Baseline (0 months) and post-intervention (3 months)]

Resting blood pressure determined by validated oscillometric device or sphygmomanometer[Baseline (0 months) and post-intervention (3 months)]

Upper and lower body strength determined in a sub-set of participants (all participants willing to attend a tertiary assessment centre for additional assessments) by using the 1RM in the leg press, chest press and seated row exercises[Baseline (0 months) and post-intervention (3 months)]

Cost-effectiveness based on costs and health outcomes to determine the incremental cost-effectiveness ratio (ICER) in dollars per quality adjusted life years (QALY) gained. QALYs will be derived from the SF-6D utility index score obtained from the SF-36 using standard methods. Cost of delivering the intervention will be monitored by research assistants.[Post-intervention (3 months)]

BMI determined by height and weight measures[Baseline (0 months) and post-intervention (3 months)]

Bone mineral density determined in a subset of participants (all participants willing to attend a tertiary assessment centre for additional assessments) using dual-energy X-ray absorptiometry [Baseline (0 months) and post-intervention (3 months)]

Cancer specific quality of life determined by the European Organisation for Research and Treatment of Cancer (QLQ-C-30) questionnaire[Baseline (0 months) and post-intervention (3 months)]

Cancer-related fatigue determined by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale[Baseline (0 months) and post-intervention (3 months)]

Safety determined by incidence and severity of any adverse events (e.g. muscle pulls or strains, falls, abnormal blood pressure, fainting, light-headedness, muscle cramps or strain, nausea, and in very rare cases heart rhythm disturbances or heart attack (risk is 1 in 49,565 patient training hours in cardiac rehabilitation)). The incidence and severity of any adverse events will be monitored and reported throughout the study by the supervising exercise physiologist. Additionally, participants will self-report incidence and severity of any adverse events using a weekly log and custom questionnaire administered after the intervention and follow-up periods. [Throughout the intervention]

Dynamic balance determined in a subset of participants (all participants willing to attend a tertiary assessment centre for additional assessments) by using the 6 metre backwards walk[Baseline (0 months) and post-intervention (3 months)]

Adherence determined by attendance of the exercise and assessment sessions[Throughout the intervention]

Physical function determined by 400 metre walk and repeated chair rise test[Baseline (0 months) and post-intervention (3 months)]

Waist and hip circumferences determined by constant tension anthropometric tape[Baseline (0 months) and post-intervention (3 months)]

Ambulatory ability determined in a subset of participants (all participants willing to attend a tertiary assessment centre for additional assessments) by using the usual and fast pace 6 metre walk[Baseline (0 months) and post-intervention (3 months)]

Static balance determined in a subset of participants (all participants willing to attend a tertiary assessment centre for additional assessments) by using the sensory organisation test performed on a Neurocom Smart Balancemaster (Neurocom, OR, USA)[Baseline (0 months) and post-intervention (3 months)]

Whole body composition determined in a subset of participants (all participants willing to attend a tertiary assessment centre for additional assessments) using dual-energy X-ray absorptiometry [Baseline (0 months) and post-intervention (3 months)]

Psychological distress determined by the Brief Symptom Inventory-18 (BSI-18)[Baseline (0 months) and post-intervention (3 months)]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Cancer Council Western Australia

Secondary Sponsor(s)

A/Prof Prue Cormie

Ethics review

Status: Approved
Approval date:
Contact:

Human Research Ethics Committee