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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RECRUITING
NA
140 participants
INTERVENTIONAL
2024-10-08
2027-01-31
Brief Summary
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Objective: The objective of the proposed study is to assess the effectiveness of a 4-month yoga program compared to a waiting list control group on musculoskeletal complaints in women with hormone-positive stage I-III breast cancer receiving endocrine treatment who report musculoskeletal complaints.
Study design: The COBRA study is a randomized controlled trial with two study arms: a yoga- and a waiting list control group.
Study population: For this study, 140 women with oestrogen-receptor positive stage I-III breast cancer on endocrine treatment (aromatase inhibitors; \>4 months) will be recruited. These women experience musculoskeletal complaints (\>3 months) which started or exacerbated after initiation of endocrine treatment. Furthermore, eligible women did not practice yoga in the last six months and are not planning to start yoga and are not highly physically active (i.e., \>150 minutes per week moderate-vigorous exercise).
Intervention: The intervention consists of two one-hour sessions/week supervised yoga and once a week 30-minute yoga exercises at home. The 4-month yoga program will be an active form of yoga, such as Easy Vinyasa yoga, which is characterized by continuous slow movements linked with breathing. The waiting list control patients will be offered an online yoga program after the 4-month study period.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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yoga group
following live yoga classes twice a week and using yoga video's at home once a week
live yoga
following live yoga classes twice a week and using yoga video's at home once a week
control group
Waiting list control group. The control group will be offered live remote yoga classes after the intervention period
live remote yoga
The control group will be offered live remote yoga classes after the intervention period
Interventions
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live yoga
following live yoga classes twice a week and using yoga video's at home once a week
live remote yoga
The control group will be offered live remote yoga classes after the intervention period
Eligibility Criteria
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Inclusion Criteria
* Use of aromatase inhibitors (\>4 months and will continue using it for at least six months),
* Have finished primary treatment (chemotherapy, radiotherapy, surgery) for at least six weeks,
* Experience musculoskeletal complaints (\>3 months, which are at least mild in severity (i.e., score of ≥ 3 for worst pain item of a modified version of the Brief Pain Inventory \[BPI\](16, 42))., which started or exacerbated after initiation of endocrine treatment,
* Be stabilized on menopausal symptom medication or antidepressants for at least three months and three weeks, respectively(19), if applicable, and
* Be able to read, speak and understand Dutch or English.
Exclusion Criteria
* Following (during the last 6 months), or planned to follow yoga classes on a structural base
* Following, or planned to follow, a structured psychological intervention during the intervention period, i.e., cognitive behavioral therapy, or unstable on psychotropic medication
* Participated in the intervention group of an exercise study during breast cancer treatment
* Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the study team
* More than 2 weeks not able to attend training sessions during the intervention period
FEMALE
No
Sponsors
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World Cancer Research Fund International
OTHER
UMC Utrecht
OTHER
Responsible Party
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Dr. Evelyn Moninkhof
Assistant professor
Principal Investigators
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Anne May, Prof. Dr.
Role: STUDY_DIRECTOR
UMC Utrecht
Locations
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University Medical Center Utrecht (UMC Utrecht)
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Stefanie Veenhuizen, MSc
Role: primary
Other Identifiers
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24-054/G; NL86325.041.24
Identifier Type: -
Identifier Source: org_study_id