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

NCT02916472 | Completed DMC

• 1 other identifier: CASE4Z16
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent and Young Adult Cancers

Keywords

AYA; exercise; cancer; cybercycling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Median change of peak pulmonary oxygen uptake (VO2Peak)

  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

Study Arms (2)

CyberCycling - Aerobic Exercise

EXPERIMENTAL

30-60 mins/week, 3 days/week supervised stationary cycling with exergaming/videogaming for 12 weeks

Behavioral: CyberCycling

Control Stretching - Resistance Bands

ACTIVE COMPARATOR

2 days/week at home for 12 weeks

Behavioral: Stretching; Behavioral: Resistance Bands

Interventions

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.

Also known as: stationary bikes, aerobic exercise

CyberCycling - 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.

Control Stretching - Resistance Bands

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.

Control Stretching - Resistance Bands

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• histologically confirmed cancer
• completed primary treatment
• approved to be contacted by the treating oncologist/nurse practitioner
• meet screening criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Motor Activity; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nora Nock, PhD

  University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 27, 2016
• Study Start: August 24, 2016
• Primary Completion: June 30, 2023
• Study Completion: February 23, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

US (1)