Effects of Yoga on Women with Breast Cancer

NCT05869721 | Completed

• 1 other identifier: 2023_Yoga_Breastcancer
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Upper Limb Functions; Sleep Quality; Upper Limb Muscle Strength; Shoulder Mobility; Heart Rate Variability; Mood; Health-related Quality of Life

Outcome Measures

Primary Outcomes (8)

• 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).

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (24)

• Upper limb muscle strength

  T1: baseline (before the study begins)

• Change from baseline Upper limb muscle strength at 4 weeks

  T2: mid-intervention (week 4)

• Change from baseline Upper limb muscle strength at 8 weeks

  T3: immediately post intervention (week 8)

• Change from baseline Upper limb muscle strength at 12 weeks

  T4: 1 month follow up (week 12)

• Shoulder mobility

  T1: baseline (before the study begins)

Study Arms (2)

Yoga group

EXPERIMENTAL

Participants will receive yoga programme over a period of eight weeks

Other: Yoga

Control group

NO INTERVENTION

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.

Interventions

Yoga OTHER

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.

Yoga group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with breast cancer (based on self-representation of gender identity)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

A university-affiliated rehabilitation laboratory

Hung Hom, Kowloon, Hong Kong

Location

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This pilot randomized controlled trial will conduct at a university-affiliated rehabilitation laboratory staring from May 2023 in Hong Kong.

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 22, 2023
• Study Start: May 4, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

HK (2)