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Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer

NCT ID: NCT02564835

Last Updated: 2018-12-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-09-30

Brief Summary

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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

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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

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Research assistants at Time 2 and 3 are blinded to which arm the participant is in.

Study Groups

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Yoga

The Yoga Program includes two 90-minute classes every week tor a total of 12 weeks.

Group Type EXPERIMENTAL

Yoga

Intervention Type OTHER

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 Activity

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).

Group Type ACTIVE_COMPARATOR

Physical Activity

Intervention Type OTHER

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.

Usual Care

Participants randomized to this arm will receive standard care only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yoga

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.

Intervention Type OTHER

Physical Activity

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\- conditions that could affect participation in yoga such as spinal disease or unstable joints
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oncology Nursing Society

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Moira Visovatti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moira Visovatti, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan School of Nursing

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00096913

Identifier Type: -

Identifier Source: org_study_id