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Completed

NCT Number: NCT02916472

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

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.

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Key information

Conditions

Adolescent and Young Adult Cancers Behavior Motor Activity Neoplasms

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CyberCycling

Behavioral

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: stationary bikes, aerobic exercise

Stretching

Behavioral

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.

Resistance Bands

Behavioral

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.

Primary outcomes

  1. Proportion of Patient Adherence as recorded by attendance log

    Time frame: 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 outcomes

  1. Median change of peak pulmonary oxygen uptake (VO2Peak)

    Time frame: Up to 12 weeks after beginning program

    A linear mixed model will also be fit to the measures of VO2peak (baseline, EOP)

  2. 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

  3. Median Physical Activity Enjoyment Scale (PAES) score

    Time frame: Up to 12 weeks after beginning program

  4. Median Flow State Scale (FSS) Score

    Time frame: Up to 12 weeks after beginning program

  5. Median Exercise Motivations (EMI) Score

    Time frame: Up to 12 weeks after beginning program

  6. Median total duration of each session

    Time frame: Up to 12 weeks after beginning program

    This is a measure of adherence

  7. Median time in total heart rate zone (THZ)

    Time frame: Up to 12 weeks after beginning program

  8. Median workload of participants while exercising

    Time frame: Up to 12 weeks after beginning program

  9. Median speed in rpm of participants while exercising

    Time frame: Up to 12 weeks after beginning program

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2023
Study completion
2024
First posted
Sep 27, 2016
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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