Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer

NCT02564835 | Completed DMC

• 1 other identifier: HUM00096913
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Program Evaluation

  The program evaluation was developed by the investigator to measure the participant experience and satisfaction with the interventions.

  At the end of the 12-week yoga and physical activity programs.

Secondary Outcomes (7)

• Attention Network Test

  Change from baseline to 6 months.

• Digit Span

  Change from baseline to 6 months

• Digit Symbol Substitution Test

  Change from baseline to 6 months

• Trail Making Test

  Change from baseline to 6 months

• Attentional Function Index

  Change from baseline to 6 months

Other Outcomes (7)

• Attendance Log

  Throughout the 12-week program.

• Adherence and Attrition Log

  From date of signed informed consent until last yoga/physical activity class or research visit - up to 6 months

• Safety Log

  At each yoga and physical activity class throughout the 12-week program

Study Arms (3)

Yoga

EXPERIMENTAL

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

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).

Other: Physical Activity

Usual Care

NO INTERVENTION

Participants randomized to this arm will receive standard care only.

Interventions

Yoga 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.

Yoga

Physical Activity 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.

Physical Activity

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Oncology Nursing Society: collaborator

Study Sites (1)

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Yoga; Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Moira Visovatti, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants at Time 2 and 3 are blinded to which arm the participant is in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 1, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)