CancerPhase 2NCT00246818
Effect of Tai Chi Vs. Structured Exercise on Physical Fitness and Stress in Cancer Survivors
A Phase 2 study testing Tai Chi Chuan in people with Cancer and Cancer Survivor, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer, Cancer Survivor
- What is being tested?
- Tai Chi Chuan
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2005to 25 Feb 2011
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Randomized Study of the Effect of Tai Chi Chuan Compared to a Structured Exercise Program on Parameters of Physical Fitness and Stress in Adult Cancer Survivors
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.
Read more
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
Read the detailed description
Diagnosis and treatment for cancer represent a major life-time stressor for any patient. While the diagnosis of a life-threatening illness is stressful, undergoing treatment for cancer including surgery, radiotherapy and chemotherapy result in stress to the patient. In addition, cancer treatment frequently is associated with fatigue, physical de-conditioning and metabolic abnormalities characteristic of the metabolic syndrome, leading to speculations that cancer therapy may render survivors more prone to developing metabolic syndrome and its sequelae, cardiovascular disease. In a recently conducted study we detected a high incidence of hyperlipidemia and increased body fat content, decreased aerobic performance and musculoskeletal functioning and a high frequency of parameters of psychological distress in long-term survivors of pediatric sarcoma. Based on these data and findings, it appears desirable to devise a program that would help cancer survivors not only to improve musculoskeletal functioning and aerobic performance, as a physical exercise program would offer, but in addition relieve psychological stress and enhance the well-being of cancer survivors after completion of treatment with multimodality therapy. Tai Chi Chuan (TCC) has been used in Asian culture for centuries to improve wellness, reduce stress, and to promote healing by improving the flow of Qi. While a number of studies have provided scientific support for these claims in different populations, a beneficial role for TCC in the management of cancer survivors has not been established.
This study aims to compare in a randomized, wait-list controlled design, the efficacy of TCC to an exercise program in improving aerobic exercise capacity and endurance, reducing stress and improving Quality of Life in adult survivors of malignant solid tumors.
- Conditions
- Cancer, Cancer Survivor
- Being tested
- Tai Chi Chuan
- Keywords
- Mind-Body, Stress Reduction, Complementary Medicine, Quality of Life, Well-being, Psychoneuroimmunology, Tai Chi, Aerobic Exercise, Cancer Survivor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi ChuanProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study start26 Oct 2005
- Primary completion31 Jul 2007
- Study completion25 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Treatment
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246818
- Sponsor's protocol ID
- 060016
- Other IDs
- 06-AT-0016
- Status last verified
- 25 Feb 2011
- First submitted
- 29 Oct 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 10452203Hughes 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.
PubMed 7077559Sabbioni 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.
PubMed 1616894
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Effect of Tai Chi Chuan Compared to a Structured Exercise Program on Parameters of Physical Fitness and Stress in Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT00246818
- Acronym / sponsor ID
- 060016
- Conditions
- Cancer, Cancer Survivor
- Keywords
- Mind-Body, Stress Reduction, Complementary Medicine, Quality of Life, Well-being, Psychoneuroimmunology, Tai Chi, Aerobic Exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- 26 Oct 2005
- Primary completion
- 31 Jul 2007 (actual)
- Study completion
- 25 Feb 2011 (actual)
- First posted
- 31 Oct 2005 (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.
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
Detailed description
Diagnosis and treatment for cancer represent a major life-time stressor for any patient. While the diagnosis of a life-threatening illness is stressful, undergoing treatment for cancer including surgery, radiotherapy and chemotherapy result in stress to the patient. In addition, cancer treatment frequently is associated with fatigue, physical de-conditioning and metabolic abnormalities characteristic of the metabolic syndrome, leading to speculations that cancer therapy may render survivors more prone to developing metabolic syndrome and its sequelae, cardiovascular disease. In a recently conducted study we detected a high incidence of hyperlipidemia and increased body fat content, decreased aerobic performance and musculoskeletal functioning and a high frequency of parameters of psychological distress in long-term survivors of pediatric sarcoma. Based on these data and findings, it appears desirable to devise a program that would help cancer survivors not only to improve musculoskeletal functioning and aerobic performance, as a physical exercise program would offer, but in addition relieve psychological stress and enhance the well-being of cancer survivors after completion of treatment with multimodality therapy. Tai Chi Chuan (TCC) has been used in Asian culture for centuries to improve wellness, reduce stress, and to promote healing by improving the flow of Qi. While a number of studies have provided scientific support for these claims in different populations, a beneficial role for TCC in the management of cancer survivors has not been established.
This study aims to compare in a randomized, wait-list controlled design, the efficacy of TCC to an exercise program in improving aerobic exercise capacity and endurance, reducing stress and improving Quality of Life in adult survivors of malignant solid tumors.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Tai Chi Chuan | Procedure or surgery | – |
Primary outcome
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.
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 2 Jul 2017.
- Background: PubMed 10452203Chernecky C. Temporal differences in coping, mood, and stress with chemotherapy. Cancer Nurs. 1999 Aug;22(4):266-76. doi: 10.1097/00002820-199908000-00003.
- Background: PubMed 7077559Hughes 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.
- Background: PubMed 1616894Sabbioni 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tai Chi Chuan in people with Cancer and Cancer Survivor, run by National Center for Complementary and Integrative Health (NCCIH) 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 2 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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.. 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 NCT00246818, which also lists 3 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 2 Jul 2017.