CyberCycling to Reduce Therapeutic Side Effects and Improve Quality of Life in AYA Cancers
NCT ID: NCT02916472
Last Updated: 2024-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2016-08-24
2024-02-23
Brief Summary
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Detailed Description
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(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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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CyberCycling - Aerobic Exercise
30-60 mins/week, 3 days/week supervised stationary cycling with exergaming/videogaming for 12 weeks
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.
Control Stretching - Resistance Bands
2 days/week at home for 12 weeks
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* completed primary treatment
* approved to be contacted by the treating oncologist/nurse practitioner
* meet screening criteria
Exclusion Criteria
* patients not available for follow-up testing
* patients with any pre-existing medical conditions that would be a contraindication to exercise.
15 Years
30 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nora Nock, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE4Z16
Identifier Type: -
Identifier Source: org_study_id
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