Effect of Tai Chi Vs. Structured Exercise on Physical Fitness and Stress in Cancer Survivors

NCT00246818 | Completed Phase 2

• 2 other identifiers: 06001606-AT-0016
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effectiveness of Tai Chi (a sequence of slow, graceful body movements) and a cardiovascular exercise fitness program in improving physical fitness and endurance, reducing stress and improving well-being in adult survivors of cancer. Tai Chi, described by some as a moving form of yoga and meditation combined, evolved from martial arts and breathing exercises in China hundreds of years ago. This study uses the 24-posture standardized Tai Chi. The movements are continuous, smooth, and natural, with the upper and lower parts of the body following each other. The entire body is always in motion, with the movements performed gently and at a uniform speed. The exercise training program uses an exercise machine. The training regimen is adjusted to maintain the individual's average training heart rate at 70 to 80 percent heart rate reserve; i.e., 220 minus the person's age. Cancer survivors of solid tumor cancers who are between 18 and 65 years of age, whose treatment included chemotherapy, biologic agents or vaccines, who have had no cancer treatment for at least 24 months, and who have had no evaluable disease within 3 months of screening for this study may be eligible to participate. Participants are randomly assigned to one of three study groups: Tai Chi, exercise training, or a waiting list. Individuals in the Tai Chi and exercise training groups participate in a supervised program for 1 hour 3 times a week for 12 weeks in the NIH Clinical Center's Rehabilitation Medicine department. Individuals assigned to the waiting list are followed for 12 weeks during the waiting period and are then assigned to either the Tai Chi or exercise program for another 12 weeks as described above. At three time points during the study-before starting the program and after 6 weeks and 12 weeks of practicing the study intervention or being on the waiting list-participants undergo the following procedures: Complete questionnaires regarding their quality of life and stress Rehabilitation medicine evaluation, including the following:

• Questions about managing their daily activities, whether their skills have changed over time, what they may or may not have been able to do, or what they may have had to overcome as a result of their previous illness and the study program they have been practicing
• Measurements of strength and mobility
• Evaluation of overall physical fitness and endurance
• Blood tests to measure blood cell counts and cholesterol, lipid, hormone and mineral levels

Conditions

Cancer; Cancer Survivor

Keywords

Mind-Body; Stress Reduction; Complementary Medicine; Quality of Life; Well-being; Psychoneuroimmunology; Tai Chi; Aerobic Exercise; Cancer Survivor

Outcome Measures

Primary Outcomes (1)

• In adult solid cancer survivors, to determine that the TCC arm will have a larger reduction in psychological stress measured by the Perceived Stress Scale compared to the aerobic exercise and wait-list arms.

Interventions

Tai Chi Chuan PROCEDURE

Eligibility Criteria

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

You may qualify if:

• To be eligible for this study, patients must meet the following criteria:
• Diagnosis of solid cancer
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
• Age 18 - 65 years at time of study enrollment
• Patients must be considered cancer survivors defined either as:
• In the first continued remission from cancer after completion of initial therapy (i.e., No Evaluable Disease (NED) for greater than 2 years after successful completion of initial cancer therapy) or
• In continued remission for greater than 5 years after completion of salvage therapy for disease recurrence
• Must have completed cancer treatment regimen that includes chemotherapy, biologic agents (e.g. IL-2, interferon) or vaccines
• Patients must have had no cancer treatment (e.g., chemotherapy, radiation therapy, cancer related surgery and/or immunotherapy) within the last 24 months
• Patients must be free of recurrence at the time of evaluation (e.g., No Evaluable Disease (NED) by history and evaluation within the past 3 months)
• Must be able to understand and sign consent.

You may not qualify if:

• Diagnosis of hematologic malignancy
• History of CAD/Angina or cardiomyopathy
• History of CVA/stroke
• Current clinical diagnosis of major depression
• Prior or current practice of Tai Chi Chuan
• Inability to perform and follow study intervention routine or study assessments/measures according to assessment of Principal Investigator, Rehabilitation Medicine Physician or TCC instructor (Dr. Adeline Ge).
• Treatment with stimulants, antidepressants (for diagnosis of major depression), neuroleptics, betablockers or cardiac antiarrhythmics.
• Current enrollment on or participation in a regular, structured exercise program.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Chernecky C. Temporal differences in coping, mood, and stress with chemotherapy. Cancer Nurs. 1999 Aug;22(4):266-76. doi: 10.1097/00002820-199908000-00003.

  PMID: 10452203 BACKGROUND

• Hughes J. Emotional reactions to the diagnosis and treatment of early breast cancer. J Psychosom Res. 1982;26(2):277-83. doi: 10.1016/0022-3999(82)90047-2.

  PMID: 7077559 BACKGROUND

• Sabbioni ME, Bovbjerg DH, Jacobsen PB, Manne SL, Redd WH. Treatment related psychological distress during adjuvant chemotherapy as a conditioned response. Ann Oncol. 1992 May;3(5):393-8. doi: 10.1093/oxfordjournals.annonc.a058214.

  PMID: 1616894 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Tai Ji

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 29, 2005
• First Posted: October 31, 2005
• Study Start: October 26, 2005
• Primary Completion: July 31, 2007
• Study Completion: February 25, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-02-25

Locations

US (1)