Colorectal NeoplasmsNCT02564835
Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer
A study testing Yoga and Physical Activity in people with Colorectal Neoplasms, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to determine if individuals with colorectal cancer enjoy yoga and to begin to assess whether yoga is effective in improving attention and immune function in individuals with colorectal cancer compared to physical activity and usual care. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Yoga and Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a history of any stage new or recuurent colorectal cancer
- great then 6 months post treatment for colorectal cancer
- report not fully recovered from the effects of cancer and cancer treatment
- no clinical signs or symptoms of brain metastasis
- normal (or corrected to normal) hearing and vision
- able to read and write English
Who cannot join
- conditions that could affect participation in yoga such as spinal disease or unstable joints
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Nursing
Ann Arbor, Michigan, 48109
About this study
The purpose of this study is to determine if individuals with colorectal cancer enjoy yoga and to begin to assess whether yoga is effective in improving attention and immune function in individuals with colorectal cancer compared to physical activity and usual care.
Read the detailed description
The proposed study will use a prospective RCT pilot design with three arms (yoga, resistance and flexibility exercise, usual care) and a total of 60 men and women who have completed therapy (> 6 months post primary or adjuvant therapy) to accomplish the specific aims. Equal numbers of men and women will be randomized into each arm of the study. Participants will be tested before, immediately after, and 3-months after treatment or similar time points for the usual care group. After data has been collected, participants who were randomized to the resistance and flexibility exercise group (active control group) or to the usual care group will be provided with the opportunity to participate in the yoga intervention.
- Conditions
- Colorectal Neoplasms
- Being tested
- Yoga, Physical Activity
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
The yoga curriculum in this study is based is based on the Integral Yoga approach that includes branches of yoga associated with cognitive and immune benefits (Hatha, Raja). Within the Integral Yoga approach, physical poses, breathing techniques and mediation practices were chosen to provide benefits to the nervous system, immune system, musculoskeletal system and gastrointestinal system. Poses will be adapted to individual needs. The number of repetitions and/or length of hold will be increased through standard progression.
Physical ActivityOther
The physical activity intervention is based on the Exercise for People Living with Cancer program. The intervention will include nine resistance exercises (e.g. squats) and 8 flexibility exercises (e.g. shoulder stretch) targeted for the whole body as well as a brief warm up and cool down (walking). Exercises will be adapted to individual needs. The number of repetitions and/or length of hold will increase through standard progression.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | The Yoga Program includes two 90-minute classes every week tor a total of 12 weeks. Receives: Other: Yoga |
| Physical Activity | Active comparator | The Physical Activity Program includes two 90-minutes classes every week for a total of 12 weeks.The intervention is based on the Exercise for People Living with Cancer program and will include nine resistance exercises (e.g. standing push up, squats, standing leg curl) and 8 flexibility exercises (e.g. shoulder stretch, quadriceps stretch, hamstrings and lower back stretch) targeted for the whole body as well as a brief warm up and cool down (walking). Receives: Other: Physical Activity |
| Usual Care | No intervention | Participants randomized to this arm will receive standard care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Evaluation
The program evaluation was developed by the investigator to measure the participant experience and satisfaction with the interventions.
Measured: At the end of the 12-week yoga and physical activity programs.
Secondary outcomes (7)
Attention Network Test
The Attention Network Test is a computerized test that asks participants to determine the direction of an arrow in the center of the screen (left or right). The center arrow can be located above or below the center fixation and is accompanied by flankers and cues. Overall attention and the three networks are assessed by measuring accuracy and response times for correct answers and how response times for correct answers are influenced by flankers, alerting cues, and spatial cues.
Measured: Change from baseline to 6 months.
Digit Span
Digit Span asks participants to repeat a series of numbers in the order they were given (Digit Span Forward) or reverse order (Digit Span Backward). The score is the number of digits recalled in the correct order before two failed trials. Digit Span is a test of attention and cognitive control.
Measured: Change from baseline to 6 months
Digit Symbol Substitution Test
The Digit Symbol Substitution Test provides participants with a key of numbers associated with symbols and ask participants to fill in numbered blank squares with the appropriate symbol. The score is the number of blank square filled in within 120 seconds. Digit Symbol Substitution test is a test of attention and cognitive control.
Measured: Change from baseline to 6 months
Trail Making Test
The Trail Making Test asks participants to draw a line connecting numbered circles (Part A) and a line connecting numbered circles and letters (Part B). The score is the time taken to complete the task. The Trail Making Test is a test of attention and cognitive control.
Measured: Change from baseline to 6 months
Attentional Function Index
The Attentional Function Index is a questionnaire that asks participants to rate their function on everyday tasks requiring attention and cognitive control from 0 (not at all) to 10 (extremely well or a great deal). The score is the average of 13 questions. The internal consistency ranges from 0.76 to 0.94 in individuals with cancer.
Measured: Change from baseline to 6 months
Functional Assessment of Cancer Therapy - Cognitive Function
The Functional Assessment of Cancer Therapy-Cognitive Function is a questionnaire that measures perceived cognitive function and impact on quality of life from 0 (not at all) to 4 (very much). It includes 27 items grouped into 5 subscales The internal consistency is 0.96 on each subscale in individuals with cancer.
Measured: Change from baseline to 6 months
Pro-inflammatory Markers
Serum levels of interleukin-1 beta, tumor necrosis factor-alpha, interleukin-6, interleukin-8, interleukin-12, interleukin-1 receptor antagonist, soluble tumor necrosis factor-receptor II, and c-reactive protein will be determined by cytometric bead array assay on a Luminex analyzer (MPXHYCTO-60K, Millipore; LXSAH, R \& D Systems). Serum levels of neopterin will be determined by enzyme-linked immunosorbent assay (RE59821, IBL International). Blood samples will be collected between 8 am and 10 am.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Oncology Nursing Society
- Responsible party
- Principal investigator, Moira Visovatti, University of Michigan
- Investigators
- Moira Visovatti, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564835
- Sponsor's protocol ID
- HUM00096913
- Status last verified
- Dec 2018
- First submitted
- 23 Sep 2015
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02564835
- Acronym / sponsor ID
- HUM00096913
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Oncology Nursing Society
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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 purpose of this study is to determine if individuals with colorectal cancer enjoy yoga and to begin to assess whether yoga is effective in improving attention and immune function in individuals with colorectal cancer compared to physical activity and usual care.
Detailed description
The proposed study will use a prospective RCT pilot design with three arms (yoga, resistance and flexibility exercise, usual care) and a total of 60 men and women who have completed therapy (> 6 months post primary or adjuvant therapy) to accomplish the specific aims. Equal numbers of men and women will be randomized into each arm of the study. Participants will be tested before, immediately after, and 3-months after treatment or similar time points for the usual care group. After data has been collected, participants who were randomized to the resistance and flexibility exercise group (active control group) or to the usual care group will be provided with the opportunity to participate in the yoga intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: YogaThe Yoga Program includes two 90-minute classes every week tor a total of 12 weeks. |
| Physical Activity | Active comparator | Other: Physical ActivityThe Physical Activity Program includes two 90-minutes classes every week for a total of 12 weeks.The intervention is based on the Exercise for People Living with Cancer program and will include nine resistance exercises (e.g. standing push up, squats, standing leg curl) and 8 flexibility exercises (e.g. shoulder stretch, quadriceps stretch, hamstrings and lower back stretch) targeted for the whole body as well as a brief warm up and cool down (walking). |
| Usual Care | No intervention | –Participants randomized to this arm will receive standard care only. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- a history of any stage new or recuurent colorectal cancer
- great then 6 months post treatment for colorectal cancer
- report not fully recovered from the effects of cancer and cancer treatment
- no clinical signs or symptoms of brain metastasis
- normal (or corrected to normal) hearing and vision
Key exclusion criteria (1 listed)
- conditions that could affect participation in yoga such as spinal disease or unstable joints
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 |
|---|---|---|
| YogaThe yoga curriculum in this study is based is based on the Integral Yoga approach that includes branches of yoga associated with cognitive and immune benefits (Hatha, Raja). Within the Integral Yoga approach, physical poses, breathing techniques and mediation practices were chosen to provide benefits to the nervous system, immune system, musculoskeletal system and gastrointestinal system. Poses will be adapted to individual needs. The number of repetitions and/or length of hold will be increased through standard progression. | Other | Yoga |
| Physical ActivityThe physical activity intervention is based on the Exercise for People Living with Cancer program. The intervention will include nine resistance exercises (e.g. squats) and 8 flexibility exercises (e.g. shoulder stretch) targeted for the whole body as well as a brief warm up and cool down (walking). Exercises will be adapted to individual needs. The number of repetitions and/or length of hold will increase through standard progression. | Other | Physical Activity |
Primary outcome
Program Evaluation
Time frame: At the end of the 12-week yoga and physical activity programs.
The program evaluation was developed by the investigator to measure the participant experience and satisfaction with the interventions.
7 secondary outcomes
Attention Network Test
Time frame: Change from baseline to 6 months.
Digit Span
Time frame: Change from baseline to 6 months
Digit Symbol Substitution Test
Time frame: Change from baseline to 6 months
Trail Making Test
Time frame: Change from baseline to 6 months
Attentional Function Index
Time frame: Change from baseline to 6 months
Functional Assessment of Cancer Therapy - Cognitive Function
Time frame: Change from baseline to 6 months
Pro-inflammatory Markers
Time frame: Change from baseline to 6 months
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 19 Dec 2018.
- 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.
Moira Visovatti, PhD principal investigator
University of Michigan
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 and Physical Activity in people with Colorectal Neoplasms, run by University of Michigan 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 6 inclusion and 1 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 19 Dec 2018. 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?
Program Evaluation (time frame: At the end of the 12-week yoga and physical activity programs.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2018.