Upper Limb FunctionsNCT05869721
Effects of Yoga on Women with Breast Cancer
A study testing Yoga in people with Upper Limb Functions and Sleep Quality, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Upper Limb Functions, Sleep Quality, Upper Limb Muscle Strength
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesHong Kong
- Study dates
- 4 May 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
The Hong Kong Polytechnic University
Hong Kong
A university-affiliated rehabilitation laboratory
Hung Hom, Kowloon
About this study
Official title: Effects of Yoga on Physical Functioning and Sleep Quality of Women with Breast Cancer: a Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Upper Limb Functions, Sleep Quality, Upper Limb Muscle Strength, Shoulder Mobility, Heart Rate Variability, Mood
- Being tested
- Yoga
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Experimental | Participants will receive yoga programme over a period of eight weeks Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: T4: 1 month follow up (week 12)
Secondary outcomes (24)
Upper limb muscle strength
Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength
Measured: T1: baseline (before the study begins)
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
Measured: T2: mid-intervention (week 4)
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
Measured: T3: immediately post intervention (week 8)
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
Measured: T4: 1 month follow up (week 12)
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
Measured: T1: baseline (before the study begins)
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
Measured: T2: mid-intervention (week 4)
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
Measured: T3: immediately post intervention (week 8)
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
Measured: T4: 1 month follow up (week 12)
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
Measured: T1: baseline (before the study begins)
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
Measured: T2: mid-intervention (week 4)
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
Measured: T3: immediately post intervention (week 8)
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
Measured: T4: 1 month follow up (week 12)
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
Measured: T1: baseline (before the study begins)
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
Measured: T2: mid-intervention (week 4)
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
Measured: T3: mid-intervention (week 8)
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
Measured: T4: 1 month follow up (week 12)
Heart rate variability
Will be recorded over a 5-minute period using a validated wearable monitor
Measured: T1: baseline (before the study begins)
Change from baseline Heart rate variability at 4 weeks
Will be recorded over a 5-minute period using a validated wearable monitor
Measured: T2: mid-intervention (week 4)
Change from baseline Heart rate variability at 8 weeks
Will be recorded over a 5-minute period using a validated wearable monitor
Measured: T3: immediately post intervention (week 8)
Change from baseline Heart rate variability at 12 weeks
Will be recorded over a 5-minute period using a validated wearable monitor
Measured: T4: 1 month follow up (week 12)
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
Measured: T1: baseline (before the study begins)
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
Measured: T2: mid-intervention (week 4)
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
Measured: T3: immediately post intervention (week 8)
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
Measured: T4: 1 month follow up (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start4 May 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb FunctionsStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This pilot randomized controlled trial will conduct at a university-affiliated rehabilitation laboratory staring from May 2023 in Hong Kong.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamay Ng, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869721
- Sponsor's protocol ID
- 2023_Yoga_Breastcancer
- Status last verified
- Oct 2024
- First submitted
- 3 May 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga on Physical Functioning and Sleep Quality of Women with Breast Cancer: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05869721
- Acronym / sponsor ID
- 2023_Yoga_Breastcancer
- Conditions
- Upper Limb Functions, Sleep Quality, Upper Limb Muscle Strength, Shoulder Mobility, Heart Rate Variability, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This pilot randomized controlled trial will conduct at a university-affiliated rehabilitation laboratory staring from May 2023 in Hong Kong.
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Other: YogaParticipants will receive yoga programme over a period of eight weeks |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaThe 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. | Other | Yoga group |
Primary outcome
Upper limb functional status, score range 0-100%, higher score means more severe disability
Time frame: T1: baseline (before the study begins).
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
Time frame: T2: mid-intervention (week 4)
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
Time frame: T3: immediately post-intervention (week 8)
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
Time frame: T4: 1 month follow up (week 12)
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
Time frame: T1: baseline (before the study begins)
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
Time frame: T2: mid-intervention (week 4)
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
Time frame: T3: immediately post intervention (week 8)
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
Time frame: T4: 1 month follow up (week 12)
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
24 secondary outcomes
Upper limb muscle strength
Time frame: T1: baseline (before the study begins)
Change from baseline Upper limb muscle strength at 4 weeks
Time frame: T2: mid-intervention (week 4)
Change from baseline Upper limb muscle strength at 8 weeks
Time frame: T3: immediately post intervention (week 8)
Change from baseline Upper limb muscle strength at 12 weeks
Time frame: T4: 1 month follow up (week 12)
Shoulder mobility
Time frame: T1: baseline (before the study begins)
Change from baseline Shoulder mobility at 4 weeks
Time frame: T2: mid-intervention (week 4)
Change from baseline Shoulder mobility at 8 weeks
Time frame: T3: immediately post intervention (week 8)
Change from baseline Shoulder mobility at 12 weeks
Time frame: T4: 1 month follow up (week 12)
Mood (including anxiety and depression symptoms)
Time frame: T1: baseline (before the study begins)
Change from baseline Mood (including anxiety and depression symptoms) at 4 weeks
Time frame: T2: mid-intervention (week 4)
Change from baseline Mood (including anxiety and depression symptoms) at 8 weeks
Time frame: T3: immediately post intervention (week 8)
Change from baseline Mood (including anxiety and depression symptoms) at 12 weeks
Time frame: T4: 1 month follow up (week 12)
Fatigue
Time frame: T1: baseline (before the study begins)
Change from baseline Fatigue at 4 weeks
Time frame: T2: mid-intervention (week 4)
Change from baseline Fatigue at 8 weeks
Time frame: T3: mid-intervention (week 8)
Change from baseline Fatigue at 12 weeks
Time frame: T4: 1 month follow up (week 12)
Heart rate variability
Time frame: T1: baseline (before the study begins)
Change from baseline Heart rate variability at 4 weeks
Time frame: T2: mid-intervention (week 4)
Change from baseline Heart rate variability at 8 weeks
Time frame: T3: immediately post intervention (week 8)
Change from baseline Heart rate variability at 12 weeks
Time frame: T4: 1 month follow up (week 12)
Health-related quality of Life
Time frame: T1: baseline (before the study begins)
Change from baseline Health-related quality of Life at 4 weeks
Time frame: T2: mid-intervention (week 4)
Change from baseline Health-related quality of Life at 8 weeks
Time frame: T3: immediately post intervention (week 8)
Change from baseline Health-related quality of Life at 12 weeks
Time frame: T4: 1 month follow up (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Upper Limb Functions
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
Recruiting
Cervical tsDCS on Stroke Patients
Functional Recovery, Motor Rehabilitation
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Upper Limb Functions and Sleep Quality, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb functional status, score range 0-100%, higher score means more severe disability (time frame: T1: baseline (before the study begins).). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.