Description:
Only a few clinical trials evaluating the potential benefits of exercise have been conducted
in adolescents and young adults (AYA) with cancer and, no prior studies have evaluated the
potential effects of 'cybercycling' (exergaming on a stationary bike) in AYA cancer
survivors. Therefore, the study aims to conduct a pilot trial to determine feasibility
(adherence, user acceptance) and to explore potential effects of a 'cybercycling' exercise
program on fitness, body composition, quality of life, sleep and cognition.
Title
- Brief Title: CyberCycling to Reduce Therapeutic Side Effects and Improve Quality of Life in AYA Cancers
- Official Title: 'Rainbow Riders': A Pilot Trial of CyberCycling to Reduce Therapeutic Side Effects and Improve Quality of Life in Adolescent and Young Adults (AYA) Diagnosed With Cancer
Clinical Trial IDs
- ORG STUDY ID:
CASE4Z16
- NCT ID:
NCT02916472
Conditions
- Adolescent and Young Adult Cancers
Purpose
Only a few clinical trials evaluating the potential benefits of exercise have been conducted
in adolescents and young adults (AYA) with cancer and, no prior studies have evaluated the
potential effects of 'cybercycling' (exergaming on a stationary bike) in AYA cancer
survivors. Therefore, the study aims to conduct a pilot trial to determine feasibility
(adherence, user acceptance) and to explore potential effects of a 'cybercycling' exercise
program on fitness, body composition, quality of life, sleep and cognition.
Detailed Description
Objectives Specific Aim 1: To evaluate the feasibility (adherence; user acceptance: exercise
tolerance, enjoyment and motivation) of performing an adaptive, moderate intensity, aerobic
exercise program on a 'cybercycle' compared to control (stretching/resistance bands) in
adolescent and young adults (AYA) with cancer.
(Exploratory) Aim 2: To explore the effects of an adaptive, moderate intensity aerobic
exercise program using a 'cybercycle' compared to control (stretching/resistance bands) on
changes in fitness, body composition, quality of life (QoL), fatigue, sleep and cognition.
Study Design/Overview:
This study is a randomized trial in 20 adolescent and young adult (AYA) cancer survivors
(15-30 years old) which will comparing two intervention arms: 1) aerobic exercise on a
'cybercycle' (stationary cycling with exergaming/videogaming); and, 2) a
stretching/resistance band 'control' condition.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| CyberCycling - Aerobic Exercise | Experimental | 30-60 mins/week, 3 days/week supervised stationary cycling with exergaming/videogaming for 12 weeks | |
| Control Stretching - Resistance Bands | Active Comparator | 2 days/week at home for 12 weeks | |
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed cancer
- completed primary treatment
- approved to be contacted by the treating oncologist/nurse practitioner
- meet screening criteria
Exclusion Criteria:
- patients unable to provide informed consent
- patients not available for follow-up testing
- patients with any pre-existing medical conditions that would be a contraindication to
exercise.
| Maximum Eligible Age: | 30 Years |
| Minimum Eligible Age: | 15 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Proportion of Patient Adherence as recorded by attendance log |
| Time Frame: | Up to 12 weeks after beginning program |
| Safety Issue: | |
| Description: | Adherence rates will be summarized separately by treatment arm with proportions and exact confidence intervals. Feasibility will be defined as an adherence of greater than or equal to 80% |
Secondary Outcome Measures
| Measure: | Median change of peak pulmonary oxygen uptake (VO2Peak) |
| Time Frame: | Up to 12 weeks after beginning program |
| Safety Issue: | |
| Description: | A linear mixed model will also be fit to the measures of VO2peak (baseline, EOP) |
| Measure: | Median Tolerance of Exercise Intensity as measured by the Preference for and Tolerance of Exercise Intensity Questionnaire (PRETIE-Q) score |
| Time Frame: | Up to 12 weeks after beginning program |
| Safety Issue: | |
| Description: | |
| Measure: | Median Physical Activity Enjoyment Scale (PAES) score |
| Time Frame: | Up to 12 weeks after beginning program |
| Safety Issue: | |
| Description: | |
| Measure: | Median Flow State Scale (FSS) Score |
| Time Frame: | Up to 12 weeks after beginning program |
| Safety Issue: | |
| Description: | |
| Measure: | Median Exercise Motivations (EMI) Score |
| Time Frame: | Up to 12 weeks after beginning program |
| Safety Issue: | |
| Description: | |
| Measure: | Median total duration of each session |
| Time Frame: | Up to 12 weeks after beginning program |
| Safety Issue: | |
| Description: | This is a measure of adherence |
| Measure: | Median time in total heart rate zone (THZ) |
| Time Frame: | Up to 12 weeks after beginning program |
| Safety Issue: | |
| Description: | |
| Measure: | Median workload of participants while exercising |
| Time Frame: | Up to 12 weeks after beginning program |
| Safety Issue: | |
| Description: | |
| Measure: | Median speed in rpm of participants while exercising |
| Time Frame: | Up to 12 weeks after beginning program |
| Safety Issue: | |
| Description: | |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Suspended |
| Lead Sponsor: | Case Comprehensive Cancer Center |
Trial Keywords
- AYA
- exercise
- cancer
- cybercycling
Last Updated
June 22, 2021
