The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer
NCT ID: NCT05820373
Last Updated: 2023-04-19
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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COMPLETED
NA
444 participants
INTERVENTIONAL
2013-05-14
2018-11-29
Brief Summary
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Detailed Description
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The aims are to test:
1. To evaluate the impact of yoga therapy on scarring contractures and range of motion in shoulder joints among women recovering from surgical treatment of breast cancer.
2. To evaluate the impact of yoga therapy on health-related quality of life and symptom distress.
Primary Hypotheses
1. Intervention and control groups mean scores on measures of shoulder movement range will show no differences at baseline or significant changes at the immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
2. Mean scores of quality of life and symptom distress between intervention and control groups at the immediate post-intervention, 3rd, 6th, and 12th month post-intervention will show no differences relative to baseline.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
The participants are masked in terms of not knowing that the yoga therapy is hypothesized to yield larger effects than the others.
Study Groups
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Intervention group
Women being allocated to the intervention group will attend a 12-week, bi-weekly, specially designed yoga therapy course.
Yoga therapy
Women being allocated to the intervention group will attend a 12-week, bi-weekly, specially designed yoga therapy course. In each yoga class, participants will be taught to perform a standardized yoga sequence including postures and breathing exercise. Each class lasts 60 minutes. A DVD demonstrating the yoga sequence will be given to each participant to prompt daily home practice.
Active control group
Women being allocated to the active control group will attend a 12-week, weekly, relaxation course.
Active control group
Women being allocated to the active control group will attend a 12-week, weekly, relaxation course. In each relaxation class, participants will be taught to learn mediation and guided relaxation, called Shavasana. Participants will be asked to lie on their back, with legs apart and their eyes closed. During the practice, participants learn how to relax the body and breath normally. Each session lasts 60 minutes.
Passive control group
The passive control intervention will be the standard post-operative exercises which are currently introduced to women following surgery, for all women allocated to the control group.
Passive control group
The passtive control intervention will be the standard post-operative exercises which are currently introduced to women following surgery, for all women allocated to the control group. A DVD demonstrating the post-operative exercise will be given to participants to practice at home daily.
Interventions
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Yoga therapy
Women being allocated to the intervention group will attend a 12-week, bi-weekly, specially designed yoga therapy course. In each yoga class, participants will be taught to perform a standardized yoga sequence including postures and breathing exercise. Each class lasts 60 minutes. A DVD demonstrating the yoga sequence will be given to each participant to prompt daily home practice.
Active control group
Women being allocated to the active control group will attend a 12-week, weekly, relaxation course. In each relaxation class, participants will be taught to learn mediation and guided relaxation, called Shavasana. Participants will be asked to lie on their back, with legs apart and their eyes closed. During the practice, participants learn how to relax the body and breath normally. Each session lasts 60 minutes.
Passive control group
The passtive control intervention will be the standard post-operative exercises which are currently introduced to women following surgery, for all women allocated to the control group. A DVD demonstrating the post-operative exercise will be given to participants to practice at home daily.
Eligibility Criteria
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Inclusion Criteria
* were newly diagnosed with breast cancer
* had completed breast cancer surgery plus chemotherapy
* were able to give consent
Exclusion Criteria
* who were practicing yoga since the diagnosis of breast cancer
* or are otherwise physically unable to yoga
18 Years
FEMALE
No
Sponsors
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hong Kong Cancer Fund
UNKNOWN
The University of Hong Kong
OTHER
Responsible Party
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Wendy Wing Tak Lam
Associate professor
Principal Investigators
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Wendy Wing Tak Lam, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Public Health, The University of Hong Kong
Other Identifiers
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Yoga2013
Identifier Type: -
Identifier Source: org_study_id
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