None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the efficacy of an exercise and balance training intervention in patients with chemotherapy-induced peripheral neuropathy (CIPN) on functional, neurophysiological, and quality of life outcomes. Who is it for? Cancer survivors at least 3 months-post treatment, aged 18 or over, and with grade 2 or 3 CIPN. Study details All participants in this study will first complete an 8 week wait period to assess the rate of adaptive improvements occurring 'naturally' (e.g. without an exercise intervention). Participants will then complete an 8 week exercise program involving a combination of supervised and unsupervised exercise sessions, totaling three 45-60 minutes sessions per week. Sessions will include a combination of cardiovascular training, strength training and balance training. Participants will be asked to complete a number of assessments and questionnaires at enrolment, after the 8 week wait period and again after the 8 week exercise program. Assessments will include physical function tests, nerve testing, and quality of life questionnaires. This pilot study is being conducted to provide insight regarding the efficacy of exercise and balance training for the treatment of CIPN.
Interventions
Following an 8-week waiting period, participants will undergo an 8-week exercise and balance training intervention consisting of three weekly 45-60 minute exercise sessions. For the first 4 weeks of the intervention, 2 weekly sessions will be conducted under 1 on 1 supervision by Accredited Exercise Physiologists, with 1 weekly session conducted at a time and place of the participant’s choosing. The final 4 weeks will consist of 1 supervised and 2 unsupervised weekly exercise sessions. Exercise
Following an 8-week waiting period, participants will undergo an 8-week exercise and balance training intervention consisting of three weekly 45-60 minute exercise sessions. For the first 4 weeks of the intervention, 2 weekly sessions will be conducted under 1 on 1 supervision by Accredited Exercise Physiologists, with 1 weekly session conducted at a time and place of the participant’s choosing. The final 4 weeks will consist of 1 supervised and 2 unsupervised weekly exercise sessions. Exercise intensity will be individually suited to each participant and progressively increased over the course of the intervention. Each exercise session will consist of approximately 10-20 minutes of cardiovascular exercise (cycle ergometer or treadmill), 20 minutes of strength training (leg press, squat, step-ups, and targeted lower leg exercises using weight machines, dumbbells, or therabands for resistance), and 15-20 minutes of balance training exercise (walking with narrow base of support and single leg standing on stable and labile surfaces, with and without visual feedback). Adherence will be monitored through an attendance log for supervised sessions and a self-report participant exercise diary for unsupervised sessions.
Sponsors
Cancer Institute NSW
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Grade 2 or 3 chemotherapy-induced peripheral neuropathy 2. At least 3 months post-chemotherapy treatment 3. Previously treated with chemotherapy for which neuropathy is a known side effect 4. Greater than 18 years of age 5. Able to provide written informed consent 6. Cleared by a physician to participate in a supervised exercise program
Exclusion criteria
Musculoskeletal impairment preventing participation (e.g. inability to walk independently)
Outcome results
None listed