CancerNCT03650322
Effects of Yoga, Strength Training and Aerobic Exercise on Cognition in Adult Cancer Survivors
A study testing Yoga, Stretching and Toning and Aerobic Walking in people with Cancer and Cancer-related Problem/Condition, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cancer-related Problem/Condition, Exercise
- What is being tested?
- Yoga, Stretching and Toning and Aerobic Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
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.
- Conditions
- Cancer, Cancer-related Problem/Condition, Exercise
- Being tested
- Yoga, Stretching and Toning, Aerobic Walking
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
12 weeks, total of 150 minutes of exercise per week.
Stretching and ToningBehavioural
12 weeks, total of 150 minutes of exercise per week.
Aerobic WalkingBehavioural
12 weeks, total of 150 minutes of exercise per week.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Practice | Experimental | 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. Receives: Behavioral: Yoga |
| Stretching and Toning | Active comparator | 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. Receives: Behavioral: Stretching and Toning |
| Aerobic Walking | Experimental | 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. Receives: Behavioral: Aerobic Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
Participants will complete part of the NIH Toolbox measures that assess cognitive function.
Measured: Change from baseline to 12 weeks will be reported
Secondary outcomes (1)
Cardiovascular Function
Participants will complete a submaximal exercise test to reach a target heart rate within 85% of the age-predicted maximum.
Measured: Change from baseline to 12 weeks will be reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Oct 2018
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neha P. Gothe, University of Illinois at Urbana-Champaign
- Investigators
- Neha Gothe, Ph.D., M.A., Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650322
- Sponsor's protocol ID
- 18922
- Status last verified
- Jun 2023
- First submitted
- 22 Aug 2018
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gothe NP, Erlenbach E, Salerno EA. Yoga improves self-reported cognitive function among cancer survivors: results from the STAYFit trial. Front Cognit. 2024 May 10;3:1334727. doi: 10.3389/fcogn.2024.1334727. eCollection 2024.
PubMed 42339439Gothe NP, Erlenbach ED, Streeter SL, Lehovec L. Effects of yoga, aerobic, and stretching and toning exercises on cognition in adult cancer survivors: protocol of the STAY Fit pilot randomized controlled trial. Trials. 2020 Sep 15;21(1):792. doi: 10.1186/s13063-020-04723-2.
PubMed 32933561
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga, Strength Training and Aerobic Exercise on Cognition in Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT03650322
- Acronym / sponsor ID
- 18922
- Conditions
- Cancer, Cancer-related Problem/Condition, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga Practice | Experimental | Behavioral: YogaParticipants 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. |
| Stretching and Toning | Active comparator | Behavioral: Stretching and ToningThis 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. |
| Aerobic Walking | Experimental | Behavioral: Aerobic WalkingParticipants 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga12 weeks, total of 150 minutes of exercise per week. | Behavioural | Yoga Practice |
| Stretching and Toning12 weeks, total of 150 minutes of exercise per week. | Behavioural | Stretching and Toning |
| Aerobic Walking12 weeks, total of 150 minutes of exercise per week. | Behavioural | Aerobic Walking |
Primary outcome
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.
1 secondary outcome
Cardiovascular Function
Time frame: Change from baseline to 12 weeks will be reported
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Derived from this study: PubMed 42339439Gothe NP, Erlenbach E, Salerno EA. Yoga improves self-reported cognitive function among cancer survivors: results from the STAYFit trial. Front Cognit. 2024 May 10;3:1334727. doi: 10.3389/fcogn.2024.1334727. eCollection 2024.
- Derived from this study: PubMed 32933561Gothe NP, Erlenbach ED, Streeter SL, Lehovec L. Effects of yoga, aerobic, and stretching and toning exercises on cognition in adult cancer survivors: protocol of the STAY Fit pilot randomized controlled trial. Trials. 2020 Sep 15;21(1):792. doi: 10.1186/s13063-020-04723-2.
- Exercise Psychology LabLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Gothe, Ph.D., M.A. principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga, Stretching and Toning and Aerobic Walking in people with Cancer and Cancer-related Problem/Condition, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: Change from baseline to 12 weeks will be reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03650322, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.