- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03650322
Effects of Yoga, Strength Training and Aerobic Exercise on Cognition in Adult Cancer Survivors
June 30, 2023 updated by: Neha P. Gothe, University of Illinois at Urbana-Champaign
The investigators propose to compare the effects of a 12-week, supervised, site-based group yoga intervention on cognitive function, functional fitness, and well-being in middle-aged cancer survivors.
Subjects will be randomly assigned to one of three exercise conditions: a yoga group, an aerobic walking group or a strength training group.
All sessions (2-3 times per week) will be led by a trained exercise leader for a total of 150 minutes of exercise each week for the 12-week intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- University of Illinois at Urbana-Champaign
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 30-70 years of age
- Cancer diagnosis
- 1 year since last cancer treatment (surgery, chemotherapy, and/or radiation)
- Not planning to receive treatment during study period
- Completion of Physical Activity Readiness Questionnaire (PAR-Q)
- Ambulatory and absence of health conditions that may be exacerbated by yoga, walking, or strength training
- Physician consent (if deemed necessary)
- Low-active, i.e. less than 150 minutes/week of moderate to vigorous exercise, no current yoga practice (including within last six months)
- Intention to remain in the Champaign-Urbana area over the study duration
- Willingness to be randomly assigned to one of the three groups (yoga, aerobic walking, strength training)
- Comfortable with reading, writing, and speaking English
Exclusion Criteria:
- Below 30 or above 70 years of age
- Cancer diagnosis of the brain
- Less than 1 year since last treatment (surgery, chemotherapy, and/or radiation) or plans to receive treatment during study
- Determined ambulatory or 'high risk' based on responses to PAR-Q
- High-active (exercising more than 150 minutes/week in the last six months)
- No consent from physician
- Intent to be away from the Champaign-Urbana area for an extended period of time during the study
- Inability to communicate effectively in English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga Practice
Participants will be led through a beginner yoga course taught by a certified yoga instructor.
Classes will meet twice a week for 75 minutes each for the duration of 12 weeks.
Sessions will focus on yoga postures, breathing, and meditative practices and may utilize mats, blocks, belts, and blankets.
|
12 weeks, total of 150 minutes of exercise per week.
|
|
Active Comparator: Stretching and Toning
This 12 week, progressive stretching and toning course will aid participants in building whole body strength and flexibility by utilizing weights, chairs, mats, and various other exercise equipment.
Sessions will meet three times a week for 50 minutes and will offer 'easy' and 'hard' modifications taught by an exercise leader.
|
12 weeks, total of 150 minutes of exercise per week.
|
|
Experimental: Aerobic Walking
Participants will partake in treadmill walking that encourages them to reach a pre-determined heart rate range.
Sessions will be conducted three times a week for 50 minutes, and offer participants to self-select a speed and incline to meet their target heart rate zone.
|
12 weeks, total of 150 minutes of exercise per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Function
Time Frame: Change from baseline to 12 weeks will be reported
|
Participants will complete part of the NIH Toolbox measures that assess cognitive function.
|
Change from baseline to 12 weeks will be reported
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular Function
Time Frame: Change from baseline to 12 weeks will be reported
|
Participants will complete a submaximal exercise test to reach a target heart rate within 85% of the age-predicted maximum.
|
Change from baseline to 12 weeks will be reported
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility: Recruitment and retention rates
Time Frame: Baseline to 12-weeks
|
Proportion of participants randomized relative to total contacts, Proportion of participants who complete follow-up questionnaires,
|
Baseline to 12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Neha Gothe, Ph.D., M.A., University of Illinois at Urbana-Champaign
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
May 30, 2020
Study Completion (Actual)
May 30, 2020
Study Registration Dates
First Submitted
August 22, 2018
First Submitted That Met QC Criteria
August 27, 2018
First Posted (Actual)
August 28, 2018
Study Record Updates
Last Update Posted (Actual)
July 5, 2023
Last Update Submitted That Met QC Criteria
June 30, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 18922
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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