Effects of Yoga on Women With Breast Cancer

Mood Clinical Trial

Official title:

Effects of Yoga on Physical Functioning and Sleep Quality of Women With Breast Cancer: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869721
• Other study ID #: 2023_Yoga_Breastcancer
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: Sarah Wong, MSc
• Phone: 39708750
• Email: ssswong[@]hkmu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health-related Quality of Life
• Heart Rate Variability
• Mood
• Sleep Quality

Intervention

Other:
• Yoga
The yoga forms are designed from the modified traditional Hatha yoga style consisting of pranayama, asana, meditation with additional relaxation elements. The selected postures will engage core and upper limb muscle and which proposed to strengthen the whole body, increase flexibility of shoulder and limbs, particularly, improve upper limb mobility and functions; also, the progression of the yoga therapy is targeted to reach the variations of postures. The combined relaxation elements reinforced to achieve restoration of the body so as to improve sleep.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong
Hong Kong	A university-affiliated rehabilitation laboratory	Hung Hom	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper limb functional status, score range 0-100%, higher score means more severe disability	Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH)	T1: baseline (before the study begins).
Primary	Change from baseline Upper limb functional status at 4 weeks	Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH), score range 0-100%, higher score means more severe disability	T2: mid-intervention (week 4)
Primary	Change from baseline Upper limb functional status at 8 weeks	Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH), score range 0-100%, higher score means more severe disability	T3: immediately post-intervention (week 8)
Primary	Change from baseline Upper limb functional status at 12 weeks	Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH), score range 0-100%, higher score means more severe disability	T4: 1 month follow up (week 12)
Primary	Sleep quality	Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep	T1: baseline (before the study begins)
Primary	Change from baseline Sleep quality at 4 weeks	Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep	T2: mid-intervention (week 4)
Primary	Change from baseline Sleep quality at 8 weeks	Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep	T3: immediately post intervention (week 8)
Primary	Change from baseline Sleep quality at 12 weeks	Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep	T4: 1 month follow up (week 12)
Secondary	Upper limb muscle strength	Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength	T1: baseline (before the study begins)
Secondary	Change from baseline Upper limb muscle strength at 4 weeks	Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength	T2: mid-intervention (week 4)
Secondary	Change from baseline Upper limb muscle strength at 8 weeks	Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength	T3: immediately post intervention (week 8)
Secondary	Change from baseline Upper limb muscle strength at 12 weeks	Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength	T4: 1 month follow up (week 12)
Secondary	Shoulder mobility	Will be determined by measuring the active range of motion using a goniometer, measures range of movement in degree, higher score means better shoulder flexibility	T1: baseline (before the study begins)
Secondary	Change from baseline Shoulder mobility at 4 weeks	Will be determined by measuring the active range of motion using a goniometer, measures range of movement in degree, higher score means better shoulder flexibility	T2: mid-intervention (week 4)
Secondary	Change from baseline Shoulder mobility at 8 weeks	Will be determined by measuring the active range of motion using a goniometer, measures range of movement in degree, higher score means better shoulder flexibility	T3: immediately post intervention (week 8)
Secondary	Change from baseline Shoulder mobility at 12 weeks	Will be determined by measuring the active range of motion using a goniometer, measures range of movement in degree, higher score means better shoulder flexibility	T4: 1 month follow up (week 12)
Secondary	Mood (including anxiety and depression symptoms)	Will be assessed using The Cantonese/Chinese version of the Hospital Anxiety and Depression questionnaire, score range 0-21, higher score means more severe anxiety and depression	T1: baseline (before the study begins)
Secondary	Change from baseline Mood (including anxiety and depression symptoms) at 4 weeks	Will be assessed using The Cantonese/Chinese version of the Hospital Anxiety and Depression questionnaire, score range 0-21, higher score means more severe anxiety and depression	T2: mid-intervention (week 4)
Secondary	Change from baseline Mood (including anxiety and depression symptoms) at 8 weeks	Will be assessed using The Cantonese/Chinese version of the Hospital Anxiety and Depression questionnaire, score range 0-21, higher score means more severe anxiety and depression	T3: immediately post intervention (week 8)
Secondary	Change from baseline Mood (including anxiety and depression symptoms) at 12 weeks	Will be assessed using The Cantonese/Chinese version of the Hospital Anxiety and Depression questionnaire, score range 0-21, higher score means more severe anxiety and depression	T4: 1 month follow up (week 12)
Secondary	Fatigue	Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue	T1: baseline (before the study begins)
Secondary	Change from baseline Fatigue at 4 weeks	Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue	T2: mid-intervention (week 4)
Secondary	Change from baseline Fatigue at 8 weeks	Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue	T3: mid-intervention (week 8)
Secondary	Change from baseline Fatigue at 12 weeks	Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue	T4: 1 month follow up (week 12)
Secondary	Heart rate variability	Will be recorded over a 5-minute period using a validated wearable monitor	T1: baseline (before the study begins)
Secondary	Change from baseline Heart rate variability at 4 weeks	Will be recorded over a 5-minute period using a validated wearable monitor	T2: mid-intervention (week 4)
Secondary	Change from baseline Heart rate variability at 8 weeks	Will be recorded over a 5-minute period using a validated wearable monitor	T3: immediately post intervention (week 8)
Secondary	Change from baseline Heart rate variability at 12 weeks	Will be recorded over a 5-minute period using a validated wearable monitor	T4: 1 month follow up (week 12)
Secondary	Health-related quality of Life	Will be assessed by the Chinese-Traditional version of the Functional Assessment of Cancer Therapy-Lymphedema questionnaire, score range 0-148, higher score means better quality of life	T1: baseline (before the study begins)
Secondary	Change from baseline Health-related quality of Life at 4 weeks	Will be assessed by the Chinese-Traditional version of the Functional Assessment of Cancer Therapy-Lymphedema questionnaire, score range 0-148, higher score means better quality of life	T2: mid-intervention (week 4)
Secondary	Change from baseline Health-related quality of Life at 8 weeks	Will be assessed by the Chinese-Traditional version of the Functional Assessment of Cancer Therapy-Lymphedema questionnaire, score range 0-148, higher score means better quality of life	T3: immediately post intervention (week 8)
Secondary	Change from baseline Health-related quality of Life at 12 weeks	Will be assessed by the Chinese-Traditional version of the Functional Assessment of Cancer Therapy-Lymphedema questionnaire, score range 0-148, higher score means better quality of life	T4: 1 month follow up (week 12)