Role of Exercise in Breast Cancer Patient Undergoing Treatment
NCT ID: NCT05009849
Last Updated: 2022-10-20
Study Results
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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ACTIVE_NOT_RECRUITING
NA
850 participants
INTERVENTIONAL
2010-11-23
2030-05-30
Brief Summary
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One of the main differences between yoga and other forms of physical activity is that yoga exercises oppose violent muscle movement and is designed to counteract fatigue through relaxation and breathing. 6 monthly Follow Up will be for 5 years followed by yearly follow up.
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Detailed Description
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Yoga is based on the practice of physical postures, breathing techniques and meditation. Philosophically, it aims at increasing the body's ability to master the mind with the goal of spiritual awareness and connection. A randomized trial of yoga in women with breast cancer undergoing radiation therapy demonstrated an improvement in impact of events scale at 3 months suggesting that the more intrusive thoughts at 1 month the greater the finding of meaning in cancer by 3 months.
* This is the first randomized controlled trial of this magnitude (850 women), which in addition to testing the impact of yoga on QOL is also powered to evaluate the impact of yoga on survival
* This is a longitudinal study measuring various phases of yoga during treatment and survivorship, with a comparative analysis of different time points and the response to yoga , which will help integrating yoga as a complementary modality
* Also, this study will help identify the long term and short term effects of this therapy in breast cancer patients and survivors
* The exercises are carefully designed keeping the phase of treatment or recovery of the breast cancer patient/survivor in focus.
* Chronic ailments have also been kept in mind (eg: which impede mobility or flexibility ie: spondylosis)
* One of the main differences between yoga and other forms of physical activity is that yoga exercises oppose violent muscle movement and is designed to counteract fatigue through relaxation and breathing.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Exercise I
Yogic and Routine Exercises (referred to as exercise I) Phase I: 1-7 days (Minimum attendance 4 days), Phase II: 8 - 14 days (Minimum attendance 4 days), Phase III: at 6-9 months or 12-15 months 1 year up gradation of exercises at 6-9 month or 12-15 months 1 year (Depending upon compliance to phase II exercises) Objective assessment at baseline, 14 days, 6-9, 12-15, 18-21, 36-39 and 54-57 months Exercise evaluation will be done at 6-9, 12-15, 30-33, 48-51 and 66-69 months
Yoga Exercises
The exercises in the Exercise I arm (Yoga and conventional exercises) will be upgraded to Phase II. Patients will be allowed to attend a minimum of four out of seven days in Phase I and II. Patients will be assessed at 6-9 months for compliance to phase II exercises. Only if patients are fulfilling the criteria for accuracy, sequence and duration of phase II exercises, will they be taught phase III exercises. Patients who are unable to do phase II exercises accurately or demonstrate non compliance to the exercise routine at first follow up visit/ 6-9 months will be re taught phase II exercises. These patients will be upgraded to phase III only if able to perform phase II adequately at assessment. Six months after completion of phase III exercises, patients will be assessed for compliance to phase III exercises. These women's will be assessed at the subsequent 6-9 month follow up and compliance will be evaluated.
Exercise II
Objective assessment at baseline, 14 days, 6-9, 12-15, 18-21, 36-39 and 54-57 months
Yoga Exercises
The exercises in the Exercise I arm (Yoga and conventional exercises) will be upgraded to Phase II. Patients will be allowed to attend a minimum of four out of seven days in Phase I and II. Patients will be assessed at 6-9 months for compliance to phase II exercises. Only if patients are fulfilling the criteria for accuracy, sequence and duration of phase II exercises, will they be taught phase III exercises. Patients who are unable to do phase II exercises accurately or demonstrate non compliance to the exercise routine at first follow up visit/ 6-9 months will be re taught phase II exercises. These patients will be upgraded to phase III only if able to perform phase II adequately at assessment. Six months after completion of phase III exercises, patients will be assessed for compliance to phase III exercises. These women's will be assessed at the subsequent 6-9 month follow up and compliance will be evaluated.
Interventions
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Yoga Exercises
The exercises in the Exercise I arm (Yoga and conventional exercises) will be upgraded to Phase II. Patients will be allowed to attend a minimum of four out of seven days in Phase I and II. Patients will be assessed at 6-9 months for compliance to phase II exercises. Only if patients are fulfilling the criteria for accuracy, sequence and duration of phase II exercises, will they be taught phase III exercises. Patients who are unable to do phase II exercises accurately or demonstrate non compliance to the exercise routine at first follow up visit/ 6-9 months will be re taught phase II exercises. These patients will be upgraded to phase III only if able to perform phase II adequately at assessment. Six months after completion of phase III exercises, patients will be assessed for compliance to phase III exercises. These women's will be assessed at the subsequent 6-9 month follow up and compliance will be evaluated.
Eligibility Criteria
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Inclusion Criteria
* Age 18-65 years
Exclusion Criteria
* Pregnant Women
* Women with physical limitations to perform exercises
* Previous history of cancer
18 Years
60 Years
FEMALE
No
Sponsors
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Tata Memorial Centre
OTHER
Responsible Party
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Nita Sukumar Nair
Professor and Surgeon (Breast Surgical Oncology Services)
Principal Investigators
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nita nair, Mch
Role: PRINCIPAL_INVESTIGATOR
Tata Memorial Centre
References
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Other Identifiers
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735
Identifier Type: -
Identifier Source: org_study_id
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