Clinical trial NCT05869721: Effects of Yoga on Women with Breast Cancer
Official title: Effects of Yoga on Physical Functioning and Sleep Quality of Women with Breast Cancer: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Functions
Sleep Quality
Upper Limb Muscle Strength
Shoulder Mobility
Heart Rate Variability
Mood
Health-related Quality of Life
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot randomized controlled trial will conduct at a university-affiliated rehabilitation laboratory staring from May 2023 in Hong Kong.
Primary purpose: TREATMENT

Brief summary: Upper limb complications and sleep disturbances are prevalent, persistent, and serious health problems in women with breast cancer. However, these problems are underrecognized in clinical practice and thus have substantial adverse impacts on the health and quality of life of women with breast cancer. As yoga practices have been shown to improve physical and psychological health in people with cancer, such practices may also alleviate upper limb complications and sleep disturbances in women with breast cancer. However, there are few evidence-based guidelines or protocols to support the integration of yoga therapy into clinical practice for managing the health conditions of women with breast cancer. Therefore, this study aims to investigate the effects of yoga therapy on improving the upper limb functions, sleep quality, and quality of life in women with breast cancer.

Detailed description: Breast cancer is the most commonly diagnosed cancer worldwide, accounting for 12% of all new cancer cases annually, and there were an estimated 2.3 million new cases worldwide in 2020. Contemporary breast cancer treatments have improved therapeutic outcomes. However, these treatments cause adverse effects; for example, more than half of women with breast cancer experience treatment-related comorbidities.

Over 60% of women with breast cancer have reported experiencing ipsilateral upper limb complications immediately post-treatment and these complications may become chronic or permanent disorders. Upper limb dysfunction is a long-term complication that comprises a complex range of symptoms and disorders, including lymphedema, pain, decreased joint mobility and muscle strength, sensory alterations, and neuropathies. Another prevalent and persistent problem that has been reported is sleep disturbance. According to a recent review, the prevalence of sleep disturbance ranged from 14 to 90% \[pooled estimated 0.4; 95% Confidence Interval (CI) 0.29 to 0.52\], and the persistence rate has been found to be more than 50%. Such side effects may lead to individual suffering and economic burdens, and can compromise the quality of life of women with breast cancer. Thus, the management of treatment-related side effects is an important part of the supportive care of women with breast cancer.

Yoga is based on ancient India philosophy, and emphasizes the integration of postures, breathing, and meditation. This mind-body practice has gained popularity over the last decades and serves as a complementary approach that is commonly used for various health conditions. This safe and trendy exercise holds attractive to female target participants. Yoga combines joint movements and breathing exercises that can help the lungs to expand, resulting in the stretching of muscles and thus increasing lymphatic circulation, which improves upper limb function. Besides, Yoga combines physical activity with mindful elements consisting of breathing and meditative practices. The practice of such mindfulness with the engagement of skeletal muscles represents a holistic approach that may decrease sleep disturbance.

Upper limb complications and sleep disturbances are prevalent, persistent, and serious health problems in women with breast cancer. However, these problems are underrecognized in clinical practice and thus have substantial adverse impacts on the health and quality of life of women with breast cancer. As yoga practices have been shown to improve physical and psychological health in people with cancer, such practices may also alleviate upper limb complications and sleep disturbances in women with breast cancer. However, there are few evidence-based guidelines or protocols to support the integration of yoga therapy into clinical practice for managing the health conditions of women with breast cancer. Therefore, this study aims to investigate the effects of yoga therapy on improving the upper limb functions, sleep quality, and quality of life in women with breast cancer. The research hypothesis of this study were (1) improvements in upper limb functions and sleep quality, could be observed in the experimental group across the assessment time points and (2) the experimental group should have better upper limb performance and sleep parameters than the control group immediately after Yoga intervention and also at the follow up.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18
* Female
* Normal cognitive function
* Diagnosed with primary breast cancer of stage I-III
* Completed cancer-related treatments (including surgery, radiotherapy, and/or chemotherapy) at least 4 weeks before enrollment except conventional medical care (e.g., hormonal therapy)

Exclusion Criteria:

* Diagnosed with distant metastasis in non-breast body part
* Diagnosed with significant diseases, such as cardiovascular, respiratory, neurological, musculoskeletal (except upper-extremity problems secondary to breast cancer), endocrine, metabolic, and psychological disorders
* Being pregnant
* Prior experiences of practicing yoga

Primary outcomes:
measure: Upper limb functional status, score range 0-100%, higher score means more severe disability
timeFrame: T1: baseline (before the study begins).
measure: Change from baseline Upper limb functional status at 4 weeks
timeFrame: T2: mid-intervention (week 4)
measure: Change from baseline Upper limb functional status at 8 weeks
timeFrame: T3: immediately post-intervention (week 8)
measure: Change from baseline Upper limb functional status at 12 weeks
timeFrame: T4: 1 month follow up (week 12)
measure: Sleep quality
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline Sleep quality at 4 weeks
timeFrame: T2: mid-intervention (week 4)
measure: Change from baseline Sleep quality at 8 weeks
timeFrame: T3: immediately post intervention (week 8)
measure: Change from baseline Sleep quality at 12 weeks
timeFrame: T4: 1 month follow up (week 12)
Secondary outcomes:
measure: Upper limb muscle strength
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline Upper limb muscle strength at 4 weeks
timeFrame: T2: mid-intervention (week 4)
measure: Change from baseline Upper limb muscle strength at 8 weeks
timeFrame: T3: immediately post intervention (week 8)
measure: Change from baseline Upper limb muscle strength at 12 weeks
timeFrame: T4: 1 month follow up (week 12)
measure: Shoulder mobility
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline Shoulder mobility at 4 weeks
timeFrame: T2: mid-intervention (week 4)
measure: Change from baseline Shoulder mobility at 8 weeks
timeFrame: T3: immediately post intervention (week 8)
measure: Change from baseline Shoulder mobility at 12 weeks
timeFrame: T4: 1 month follow up (week 12)
measure: Mood (including anxiety and depression symptoms)
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline Mood (including anxiety and depression symptoms) at 4 weeks
timeFrame: T2: mid-intervention (week 4)
measure: Change from baseline Mood (including anxiety and depression symptoms) at 8 weeks
timeFrame: T3: immediately post intervention (week 8)
measure: Change from baseline Mood (including anxiety and depression symptoms) at 12 weeks
timeFrame: T4: 1 month follow up (week 12)
measure: Fatigue
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline Fatigue at 4 weeks
timeFrame: T2: mid-intervention (week 4)
measure: Change from baseline Fatigue at 8 weeks
timeFrame: T3: mid-intervention (week 8)
measure: Change from baseline Fatigue at 12 weeks
timeFrame: T4: 1 month follow up (week 12)
measure: Heart rate variability
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline Heart rate variability at 4 weeks
timeFrame: T2: mid-intervention (week 4)
measure: Change from baseline Heart rate variability at 8 weeks
timeFrame: T3: immediately post intervention (week 8)
measure: Change from baseline Heart rate variability at 12 weeks
timeFrame: T4: 1 month follow up (week 12)
measure: Health-related quality of Life
timeFrame: T1: baseline (before the study begins)
measure: Change from baseline Health-related quality of Life at 4 weeks
timeFrame: T2: mid-intervention (week 4)
measure: Change from baseline Health-related quality of Life at 8 weeks
timeFrame: T3: immediately post intervention (week 8)
measure: Change from baseline Health-related quality of Life at 12 weeks
timeFrame: T4: 1 month follow up (week 12)
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: A university-affiliated rehabilitation laboratory
state: Kowloon
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: