Clinical trial NCT02916472: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent and Young Adult Cancers
Keywords: AYA
exercise
cancer
cybercycling
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 9
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Primary outcomes:
measure: Proportion of Patient Adherence as recorded by attendance log
timeFrame: Up to 12 weeks after beginning program
Secondary outcomes:
measure: Median change of peak pulmonary oxygen uptake (VO2Peak)
timeFrame: Up to 12 weeks after beginning program
measure: Median Tolerance of Exercise Intensity as measured by the Preference for and Tolerance of Exercise Intensity Questionnaire (PRETIE-Q) score
timeFrame: Up to 12 weeks after beginning program
measure: Median Physical Activity Enjoyment Scale (PAES) score
timeFrame: Up to 12 weeks after beginning program
measure: Median Flow State Scale (FSS) Score
timeFrame: Up to 12 weeks after beginning program
measure: Median Exercise Motivations (EMI) Score
timeFrame: Up to 12 weeks after beginning program
measure: Median total duration of each session
timeFrame: Up to 12 weeks after beginning program
measure: Median time in total heart rate zone (THZ)
timeFrame: Up to 12 weeks after beginning program
measure: Median workload of participants while exercising
timeFrame: Up to 12 weeks after beginning program
measure: Median speed in rpm of participants while exercising
timeFrame: Up to 12 weeks after beginning program
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
name: Nora Nock, PhD
role: PRINCIPAL_INVESTIGATOR
References: