Clinical Trials /

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

NCT02916472

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.

Related Conditions:
  • Cancer
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

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.

      Aim 1 Hypothesis: The investigators hypothesize that AYA with cancer will be able to adhere
      to and tolerate the moderate intensity cycling program and, patients in the 'cybercycling'
      exercise program will have greater exercise tolerance, exercise enjoyment and exercise
      motivation.

      (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.

      Aim 2 Hypothesis: The investigators hypothesize that patients in the 'cybercycling' program
      will have greater improvements in fitness, fatigue, QoL, sleep and cognitive test scores as
      well as greater reductions in body fat and improved maintenance of fat-free mass compared
      those in the control condition.

      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

NameTypeDescriptionInterventions
CyberCycling - Aerobic ExerciseExperimental30-60 mins/week, 3 days/week supervised stationary cycling with exergaming/videogaming for 12 weeks
    Control Stretching - Resistance BandsActive Comparator2 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:Early Phase 1
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Case Comprehensive Cancer Center

      Trial Keywords

      • AYA
      • exercise
      • cancer
      • cybercycling

      Last Updated

      January 5, 2017