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

'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

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.

Study Overview

• Status: Completed
• Conditions: Adolescent and Young Adult Cancers
• Intervention / Treatment: Behavioral: CyberCycling; Behavioral: Stretching; Behavioral: Resistance Bands

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CyberCycling - Aerobic Exercise; 30-60 mins/week, 3 days/week supervised stationary cycling with exergaming/videogaming for 12 weeks	Behavioral: CyberCycling; All exercise training will be performed under the supervision of a qualified exercise trainer certified in Advanced Cardiac Life Support. Participants in the exercise groups will be asked to perform aerobic exercise on a stationary bike ('cybercycle') 3 days per week for 12 weeks. Exercise intensity and duration will be based on a progressive program and adapted, as needed, based on the participants' tolerability. Heart rate will be monitored throughout the exercise session and Rating of Perceived Exertion (RPE) monitored at least every 10 minutes. The target heart rate (THR) zone will be determined using the Karvonen formula.; Other Names: aerobic exercise; stationary bikes
Active Comparator: Control Stretching - Resistance Bands; 2 days/week at home for 12 weeks	Behavioral: Stretching; Participants randomized to the control condition will receive a progressive resistance training program with TheraBands™ and a stretching program to complete at home 2 days/week for 12 weeks. The resistance band program will include upper body and lower body exercises. Participants will be provided with two different colored resistance bands (lighter colored - easier resistance; darker colored - harder resistance). Participants will start by completing 1-2 sets, 2 days/week with the easier/lighter band for the first 4 weeks, progress to 2-3 sets, 2 days/week with the easier band for the next 4 weeks; and, then, progress to 1-2 sets with the darker/harder band for the last 4 weeks. In addition, all participants in the 'control' condition will be advised to conduct upper body and lower body stretches 2 days/week. All resistance band exercises and stretches will be demonstrated to the participant by the exercise physiologist before the 12 week program begins.; Behavioral: Resistance Bands; Participants randomized to the control condition will receive a progressive resistance training program with TheraBands™ and a stretching program to complete at home 2 days/week for 12 weeks. The resistance band program will include upper body and lower body exercises and will be provided with two different colored resistance bands (one lighter colored for easier resistance; one darker colored for a harder resistance). Participants will start by completing 1-2 sets, 2 days/week with the easier/lighter band for the first 4 weeks, progress to 2-3 sets, 2 days/week with the easier band for the next 4 weeks; and, then, progress to 1-2 sets with the darker/harder band for the last 4 weeks. In addition, all participants in the 'control' condition will be advised to conduct upper body and lower body stretches 2 days/week. All resistance band exercises and stretches will be demonstrated to the participants by the exercise physiologist before the 12 week program begins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patient Adherence as recorded by attendance log	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%	Up to 12 weeks after beginning program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median change of peak pulmonary oxygen uptake (VO2Peak)	A linear mixed model will also be fit to the measures of VO2peak (baseline, EOP)	Up to 12 weeks after beginning program
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 Exercise Motivations (EMI) Score		Up to 12 weeks after beginning program
Median total duration of each session	This is a measure of adherence	Up to 12 weeks after beginning program
Median time in total heart rate zone (THZ)		Up to 12 weeks after beginning program
Median workload of participants while exercising		Up to 12 weeks after beginning program
Median speed in rpm of participants while exercising		Up to 12 weeks after beginning program

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Nora Nock, PhD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2016
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimated): September 27, 2016

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: exercise; cancer; AYA; cybercycling
• Other Study ID Numbers: CASE4Z16