CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 850 enrolled
Drug / intervention
Yoga Exercisesother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05009849
NCT05009849N/AActive

Randomized Controlled Evaluating the Role of Exercise in Women Undergoing Treatment for Breast Cancer

Tata Memorial Centre·interventional·Posted Aug 18, 2021·Updated Oct 20, 2022

In Brief

A clinical study evaluating Yoga Exercises for Breast Cancer Patients. Active but no longer recruiting, targeting 850 participants.

Detailed Summary

Randomized controlled trial to evaluate the impact of yoga on QOL is also powered to evaluate the impact of yoga on survival. Study involves various phases of yoga(divided in three phases: Phase I/II/III) 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/AActive
20112012201320142015201620172018201920202021202220232024202520262027202820292030
First PostedAug 18, 2021
Enrollment StartNov 23, 2010
Primary CompletionMay 24, 2025
Study CompletionMay 30, 2030
TodayJul 2, 2026
Enrollment to primary: 14.5 yearsPosted 4.9 years ago

Interventions

Yoga Exercisesother

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.