CyberCycling to Reduce Therapeutic Side Effects and Improve Quality of Life in AYA Cancers

Not Applicable

Completed

• Conditions: Adolescent and Young Adult Cancers
• Interventions: Behavioral: CyberCycling; Behavioral: Stretching; Behavioral: Resistance Bands

• Registration Number: NCT02916472
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2016-08-24
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Primary Completion: 2023-06-30
• Status Verified: 2024-02
• Study Completion: 2024-02-23
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Stretching - Resistance Bands	Resistance Bands	2 days/week at home for 12 weeks
CyberCycling - Aerobic Exercise	CyberCycling	30-60 mins/week, 3 days/week supervised stationary cycling with exergaming/videogaming for 12 weeks
Control Stretching - Resistance Bands	Stretching	2 days/week at home for 12 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of Patient Adherence as recorded by attendance log	Up to 12 weeks after beginning program	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

Name	Time	Method
Median Tolerance of Exercise Intensity as measured by the Preference for and Tolerance of Exercise Intensity Questionnaire (PRETIE-Q) score	Up to 12 weeks after beginning program
Median Physical Activity Enjoyment Scale (PAES) score	Up to 12 weeks after beginning program
Median Flow State Scale (FSS) Score	Up to 12 weeks after beginning program
Median total duration of each session	Up to 12 weeks after beginning program	This is a measure of adherence
Median workload of participants while exercising	Up to 12 weeks after beginning program
Median Exercise Motivations (EMI) Score	Up to 12 weeks after beginning program
Median speed in rpm of participants while exercising	Up to 12 weeks after beginning program
Median change of peak pulmonary oxygen uptake (VO2Peak)	Up to 12 weeks after beginning program	A linear mixed model will also be fit to the measures of VO2peak (baseline, EOP)
Median time in total heart rate zone (THZ)	Up to 12 weeks after beginning program

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States