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Effects of Yoga on Women With Breast Cancer

Primary Purpose

Upper Limb Functions, Sleep Quality, Upper Limb Muscle Strength

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Yoga
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Limb Functions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • A university-affiliated rehabilitation laboratoryRecruiting
  • The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga group

Control group

Arm Description

Participants will receive yoga programme over a period of eight weeks

The participants in the control group will receive usual care, and complete all assessments on the same timeline as the intervention group. They will be offered yoga programme at the completion of the final measurement.

Outcomes

Primary Outcome Measures

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)
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
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
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
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
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
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
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

Secondary Outcome Measures

Upper limb muscle strength
Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Heart rate variability
Will be recorded over a 5-minute period using a validated wearable monitor
Change from baseline Heart rate variability at 4 weeks
Will be recorded over a 5-minute period using a validated wearable monitor
Change from baseline Heart rate variability at 8 weeks
Will be recorded over a 5-minute period using a validated wearable monitor
Change from baseline Heart rate variability at 12 weeks
Will be recorded over a 5-minute period using a validated wearable monitor
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
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
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
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

Full Information

First Posted
May 3, 2023
Last Updated
September 20, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05869721
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Limb Functions, Sleep Quality, Upper Limb Muscle Strength, Shoulder Mobility, Heart Rate Variability, Mood, Health-related Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This pilot randomized controlled trial will conduct at a university-affiliated rehabilitation laboratory staring from May 2023 in Hong Kong.
Masking
Outcomes Assessor
Masking Description
After the baseline assessment, all eligible participants will be allocated randomly in a 1:1 ratio to either (1) experimental group which received yoga programme over a period of eight weeks, or (2) wait-list control group. The research assistant, who is responsible for allocation, is independent from the data collection and analysis, and the intervention. The participants will be reminded not to disclose information related to group allocation to the assessors to prevent possible bias during measurement. All assessments will be performed by an assessor who is blinded to the group allocation and not involved in the delivery of the intervention.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga group
Arm Type
Experimental
Arm Description
Participants will receive yoga programme over a period of eight weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants in the control group will receive usual care, and complete all assessments on the same timeline as the intervention group. They will be offered yoga programme at the completion of the final measurement.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper limb functional status, score range 0-100%, higher score means more severe disability
Description
Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH)
Time Frame
T1: baseline (before the study begins).
Title
Change from baseline Upper limb functional status at 4 weeks
Description
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
Time Frame
T2: mid-intervention (week 4)
Title
Change from baseline Upper limb functional status at 8 weeks
Description
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
Time Frame
T3: immediately post-intervention (week 8)
Title
Change from baseline Upper limb functional status at 12 weeks
Description
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
Time Frame
T4: 1 month follow up (week 12)
Title
Sleep quality
Description
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
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline Sleep quality at 4 weeks
Description
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
Time Frame
T2: mid-intervention (week 4)
Title
Change from baseline Sleep quality at 8 weeks
Description
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
Time Frame
T3: immediately post intervention (week 8)
Title
Change from baseline Sleep quality at 12 weeks
Description
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
Time Frame
T4: 1 month follow up (week 12)
Secondary Outcome Measure Information:
Title
Upper limb muscle strength
Description
Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline Upper limb muscle strength at 4 weeks
Description
Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength
Time Frame
T2: mid-intervention (week 4)
Title
Change from baseline Upper limb muscle strength at 8 weeks
Description
Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength
Time Frame
T3: immediately post intervention (week 8)
Title
Change from baseline Upper limb muscle strength at 12 weeks
Description
Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength
Time Frame
T4: 1 month follow up (week 12)
Title
Shoulder mobility
Description
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
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline Shoulder mobility at 4 weeks
Description
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
Time Frame
T2: mid-intervention (week 4)
Title
Change from baseline Shoulder mobility at 8 weeks
Description
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
Time Frame
T3: immediately post intervention (week 8)
Title
Change from baseline Shoulder mobility at 12 weeks
Description
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
Time Frame
T4: 1 month follow up (week 12)
Title
Mood (including anxiety and depression symptoms)
Description
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
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline Mood (including anxiety and depression symptoms) at 4 weeks
Description
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
Time Frame
T2: mid-intervention (week 4)
Title
Change from baseline Mood (including anxiety and depression symptoms) at 8 weeks
Description
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
Time Frame
T3: immediately post intervention (week 8)
Title
Change from baseline Mood (including anxiety and depression symptoms) at 12 weeks
Description
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
Time Frame
T4: 1 month follow up (week 12)
Title
Fatigue
Description
Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline Fatigue at 4 weeks
Description
Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue
Time Frame
T2: mid-intervention (week 4)
Title
Change from baseline Fatigue at 8 weeks
Description
Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue
Time Frame
T3: mid-intervention (week 8)
Title
Change from baseline Fatigue at 12 weeks
Description
Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue
Time Frame
T4: 1 month follow up (week 12)
Title
Heart rate variability
Description
Will be recorded over a 5-minute period using a validated wearable monitor
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline Heart rate variability at 4 weeks
Description
Will be recorded over a 5-minute period using a validated wearable monitor
Time Frame
T2: mid-intervention (week 4)
Title
Change from baseline Heart rate variability at 8 weeks
Description
Will be recorded over a 5-minute period using a validated wearable monitor
Time Frame
T3: immediately post intervention (week 8)
Title
Change from baseline Heart rate variability at 12 weeks
Description
Will be recorded over a 5-minute period using a validated wearable monitor
Time Frame
T4: 1 month follow up (week 12)
Title
Health-related quality of Life
Description
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
Time Frame
T1: baseline (before the study begins)
Title
Change from baseline Health-related quality of Life at 4 weeks
Description
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
Time Frame
T2: mid-intervention (week 4)
Title
Change from baseline Health-related quality of Life at 8 weeks
Description
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
Time Frame
T3: immediately post intervention (week 8)
Title
Change from baseline Health-related quality of Life at 12 weeks
Description
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
Time Frame
T4: 1 month follow up (week 12)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with breast cancer (based on self-representation of gender identity)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Wong, MSc
Phone
39708750
Email
ssswong@hkmu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Shamay Ng, PhD
Phone
27664889
Email
shamay.ng@polyu.edu.hk
Facility Information:
Facility Name
A university-affiliated rehabilitation laboratory
City
Hung Hom
State/Province
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Wong, MSc
Phone
39708750
First Name & Middle Initial & Last Name & Degree
TW Liu, PhD
Phone
39708714
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shamay Ng, PhD
Phone
27664889
Email
Shamay.Ng@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Shamay SM Ng, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The datasets of the study will only be available from the corresponding author on reasonable request after the findings being published in peer-reviewed journal.

Learn more about this trial

Effects of Yoga on Women With Breast Cancer

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