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

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ClinicalTrials.gov Identifier: NCT02916472
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Adolescent and Young Adult Cancers Behavioral: CyberCycling Behavioral: Stretching Behavioral: Resistance Bands Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 24, 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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. Patients 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 patient's 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

Active Comparator: Control Stretching - Resistance Bands
2 days/week at home for 12 weeks
Behavioral: Stretching
Patients 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. Patients will be provided with two different colored resistance bands (one lighter colored for easier resistance; one darker colored for a harder resistance). Patients will be instructed to 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 patients 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 patient by the exercise physiologist before the 12 week program begins.

Behavioral: Resistance Bands
Patients 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. Patients will be provided with two different colored resistance bands (one lighter colored for easier resistance; one darker colored for a harder resistance). Patients will be instructed to 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 patients 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 patient by the exercise physiologist before the 12 week program begins.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916472


Contacts
Contact: Nora L Nock, PhD 216-368-5633 nln@case.edu

Locations
United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nora L Nock, PhD    216-368-5653    nln@case.edu   
Principal Investigator: Nora L Nock, PhD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Nora L Nock, PhD University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02916472     History of Changes
Other Study ID Numbers: CASE4Z16
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by Case Comprehensive Cancer Center:
AYA
exercise
cancer
cybercycling