CancerNCT04692233
Qigong to Improve Frailty Among Older Cancer Survivors
A study testing Qigong Baduanjin and Light flexibility exercise in people with Cancer and Frailty, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The objective of the study is to examine the effects of a 16-week Baduanjin qigong intervention on frailty, physical performance, psychological well-being, and health-related quality of life (HRQoL) among post-treatment older cancer survivors. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer, Frailty, Survivorship
- What is being tested?
- Qigong Baduanjin and Light flexibility exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 2 sitesHong Kong
- Study dates
- 19 Feb 2021to 31 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged ≥65
- diagnosed with stage I-III non-metastatic cancer
- completed primary treatment with curative intent (surgery, chemotherapy, and/or radiation therapy) 6 months to 5 years prior to baseline assessments with no recurrence or occurrence of additional cancers
- classified as pre-frail or frail based on Fried frailty criteria
- can communicate in Cantonese or Putonghua
- written informed consent
Who cannot join
- regular qigong training or other mind body intervention (once or more per week) within the previous 6 months
- medical conditions affecting mobility, predisposing to falls, or precluding qigong practice (e.g., neurological disease, musculoskeletal disorder, recent myocardial infarction, breathing difficulties requiring oxygen)
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital
Hong Kong, 000
Pamela Youde Nethersole Eastern Hospital
Hong Kong
About this study
Official title: Qigong to Improve Frailty Among Older Cancer Survivors: A Randomized Controlled Trial
The objective of the study is to examine the effects of a 16-week Baduanjin qigong intervention on frailty, physical performance, psychological well-being, and health-related quality of life (HRQoL) among post-treatment older cancer survivors. This will be a randomized controlled, assessor-blind trial conforming to the CONSORT guidelines. A total of 226 cancer survivors aged over 65 who have completed curative treatment and screened as pre-frail or frail will be recruited and randomized into intervention and control groups. It is expected that upon intervention completion, the intervention group will demonstrate greater reversed frailty status, more improvements in physical performance, better psychological well-being, and enhanced HRQoL compared to the control group. Study instruments will be Fried Phenotype Criteria, Edmonton Frail Scale, Short Physical Performance Battery, Geriatric Depression Scale, European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire, and a background questionnaire. The intervention comprises of 1-hour qigong group training twice a week for 8 weeks, then 1-hour weekly follow-up group practice for 8 weeks and self-practice. The control group participants will attend light flexibility exercise group sessions at the same duration and frequency as the intervention group. Intention-to-treat analysis will be performed.
Read the detailed description
The number of cancer survivors is rising worldwide. For example, in the United States, the number of cancer survivors is projected to increase by 31%, from 16.9 million in 2019 to 22.2 million by 2030, of which two-thirds are aged 65 or above. Hong Kong is also facing a growing number of cancer survivors, especially in older adults, due to advances in early detection and treatments and an aging population. The Hong Kong Cancer Strategy 2019 launched by the Hong Kong Government and Hospital Authority seeks to enhance cancer survivorship and surveillance management.
Older cancer survivors, making up the majority of survivors, tend to suffer from the combined effect of aging and long-term impacts of cancer, resulting in higher morbidity rates and poorer health-related quality of life than older adults without a cancer history. Tailored care for survivorship in older adults with cancer is highly important to reduce healthcare and economic burdens. In geriatric oncology, frailty status is an emerging health indicator with prognostic value. Nearly 80% of older cancer survivors have pre-frailty and frailty status that is linked to adverse health outcomes such as disability, impaired quality of life, falls, and death. There is a tremendous need to develop effective lifestyle interventions to reverse frailty status in the older cancer survivors. However, many clinical trials exclude participants older than 65 years old, and in real-world practice, many clinicians and policymakers advocate lifestyle modifications for older survivors less frequently than for younger survivors. The proposed project responds to an urgent research agenda in cancer survivorship that calls for interventions for addressing frailty.
The primary aim of this study is to evaluate the effect of a 16-week Baduanjin intervention on reversing frailty status among pre-frail and frail older cancer survivors. Reversal of frailty status is expected to be accompanied by improvements in patients' functioning, psychological well-being, and quality of life, and can reduce health service utilization and healthcare costs. Baduanjin is a simple form of qigong and can be performed by participants as and when needed after appropriate training. If the intervention proves effective, the widespread incorporation of qigong into treatment recommendations for cancer survivors can be easily translated into practice with little healthcare professional or patient burden.
- Conditions
- Cancer, Frailty, Survivorship, Elderly
- Being tested
- Qigong Baduanjin, Light flexibility exercise
- Keywords
- Qigong, Baduanjin, Cancer survivors, Frailty
- Medical subject headings
- Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong BaduanjinBehavioural
Qigong Baduanjin will comprise eight standardized movements. It is practiced as a combination of body movements, breath control, and mindful meditation, which is designed to improve qi function.
Light flexibility exerciseBehavioural
Each session will include seated and standing stretches that target upper (neck, arms, upper back, shoulders, back, and chest) and lower body (quadriceps, hamstrings, calves, and hips), as well as trunk rotations.
| Study group | Role | What they receive |
|---|---|---|
| Qigong | Experimental | The entire intervention will last 16 weeks, including 1-hour supervised training sessions twice a week during weeks 1 to 8 (training; 16 hours), and 1-hour supervised weekly follow-up sessions during weeks 9 to 16 (follow-up; 8 hours). The sessions will be supervised by an experienced qigong master. Throughout the intervention period, participants will be asked to self-practice BQ for 30 minutes twice a week from weeks 1 to 8, and then three times a week from weeks 9 to 16 (20 hours). Receives: Behavioral: Qigong Baduanjin |
| Light flexibility exercise | Active comparator | The control group will practice light flexibility exercise without any abdominal breathing and meditation techniques. The duration and frequency of supervised sessions and self-practice will be identical to the qigong sessions. The supervised sessions will be conducted by a certified exercise trainer. Receives: Behavioral: Light flexibility exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in frailty status
Participants' frailty status will be assessed using the Fried frailty criteria, which consists of 5 criteria: slowness , weakness , unintentional weight loss , exhaustion and low activity. Patients with no criteria are considered robust, patients with 1 or 2 criteria are considered pre-frail, and patients with ≥3 criteria are considered frail.
Measured: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Secondary outcomes (4)
Improvement in frailty scores
The Edmonton Frail Scale will be used to capture changes in frailty as a continuous score. As a multidimensional view, it will complement the physical-based Fried criteria regarding the intervention effect. The scale consists of 11 items, which cover nine domains (cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance). The higher total scores represent more severe frailty states.
Measured: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Physical performance
Short Physical Performance Battery is an objective assessment tool used to measure the physical performance of participants in three functional tasks.
Measured: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Psychological well-being
The Short-Form Geriatric Depression Scale (15 items) will be used to measure psychological well-being. Scores range from 0 to 15, with higher scores representing more severe depressive symptoms.
Measured: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Health-related quality of life
European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 (30 items) will be used to assess health-related quality of life specifically in cancer patients. The questionnaire is composed of five functional scales, three symptom scales, a global health status / QoL scale, and six single items. scale. Scores of all subscales and single-item measures range from 0 to 100. Higher scores for functional scales represent higher level of functioning, global health status/quality of life, but higher scores for a symptom scale / item represent a higher level of symptom severity.
Measured: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start19 Feb 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Shuk-Ting, The University of Hong Kong
- Investigators
- Denise Shuk Ting Cheung, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692233
- Sponsor's protocol ID
- UW19550
- Status last verified
- May 2025
- First submitted
- 30 Dec 2020
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on reasonable request as decided by the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qigong to Improve Frailty Among Older Cancer Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04692233
- Acronym / sponsor ID
- UW19550
- Conditions
- Cancer, Frailty, Survivorship, Elderly
- Keywords
- Qigong, Baduanjin, Cancer survivors, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 31 Dec 2020 (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.
The objective of the study is to examine the effects of a 16-week Baduanjin qigong intervention on frailty, physical performance, psychological well-being, and health-related quality of life (HRQoL) among post-treatment older cancer survivors. This will be a randomized controlled, assessor-blind trial conforming to the CONSORT guidelines. A total of 226 cancer survivors aged over 65 who have completed curative treatment and screened as pre-frail or frail will be recruited and randomized into intervention and control groups. It is expected that upon intervention completion, the intervention group will demonstrate greater reversed frailty status, more improvements in physical performance, better psychological well-being, and enhanced HRQoL compared to the control group. Study instruments will be Fried Phenotype Criteria, Edmonton Frail Scale, Short Physical Performance Battery, Geriatric Depression Scale, European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire, and a background questionnaire. The intervention comprises of 1-hour qigong group training twice a week for 8 weeks, then 1-hour weekly follow-up group practice for 8 weeks and self-practice. The control group participants will attend light flexibility exercise group sessions at the same duration and frequency as the intervention group. Intention-to-treat analysis will be performed.
Detailed description
The number of cancer survivors is rising worldwide. For example, in the United States, the number of cancer survivors is projected to increase by 31%, from 16.9 million in 2019 to 22.2 million by 2030, of which two-thirds are aged 65 or above. Hong Kong is also facing a growing number of cancer survivors, especially in older adults, due to advances in early detection and treatments and an aging population. The Hong Kong Cancer Strategy 2019 launched by the Hong Kong Government and Hospital Authority seeks to enhance cancer survivorship and surveillance management.
Older cancer survivors, making up the majority of survivors, tend to suffer from the combined effect of aging and long-term impacts of cancer, resulting in higher morbidity rates and poorer health-related quality of life than older adults without a cancer history. Tailored care for survivorship in older adults with cancer is highly important to reduce healthcare and economic burdens. In geriatric oncology, frailty status is an emerging health indicator with prognostic value. Nearly 80% of older cancer survivors have pre-frailty and frailty status that is linked to adverse health outcomes such as disability, impaired quality of life, falls, and death. There is a tremendous need to develop effective lifestyle interventions to reverse frailty status in the older cancer survivors. However, many clinical trials exclude participants older than 65 years old, and in real-world practice, many clinicians and policymakers advocate lifestyle modifications for older survivors less frequently than for younger survivors. The proposed project responds to an urgent research agenda in cancer survivorship that calls for interventions for addressing frailty.
The primary aim of this study is to evaluate the effect of a 16-week Baduanjin intervention on reversing frailty status among pre-frail and frail older cancer survivors. Reversal of frailty status is expected to be accompanied by improvements in patients' functioning, psychological well-being, and quality of life, and can reduce health service utilization and healthcare costs. Baduanjin is a simple form of qigong and can be performed by participants as and when needed after appropriate training. If the intervention proves effective, the widespread incorporation of qigong into treatment recommendations for cancer survivors can be easily translated into practice with little healthcare professional or patient burden.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong | Experimental | Behavioral: Qigong BaduanjinThe entire intervention will last 16 weeks, including 1-hour supervised training sessions twice a week during weeks 1 to 8 (training; 16 hours), and 1-hour supervised weekly follow-up sessions during weeks 9 to 16 (follow-up; 8 hours). The sessions will be supervised by an experienced qigong master. Throughout the intervention period, participants will be asked to self-practice BQ for 30 minutes twice a week from weeks 1 to 8, and then three times a week from weeks 9 to 16 (20 hours). |
| Light flexibility exercise | Active comparator | Behavioral: Light flexibility exerciseThe control group will practice light flexibility exercise without any abdominal breathing and meditation techniques. The duration and frequency of supervised sessions and self-practice will be identical to the qigong sessions. The supervised sessions will be conducted by a certified exercise trainer. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- aged ≥65
- diagnosed with stage I-III non-metastatic cancer
- completed primary treatment with curative intent (surgery, chemotherapy, and/or radiation therapy) 6 months to 5 years prior to baseline assessments with no recurrence or occurrence of additional cancers
- classified as pre-frail or frail based on Fried frailty criteria
- can communicate in Cantonese or Putonghua
Key exclusion criteria (2 listed)
- regular qigong training or other mind body intervention (once or more per week) within the previous 6 months
- medical conditions affecting mobility, predisposing to falls, or precluding qigong practice (e.g., neurological disease, musculoskeletal disorder, recent myocardial infarction, breathing difficulties requiring oxygen)
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 |
|---|---|---|
| Qigong BaduanjinQigong Baduanjin will comprise eight standardized movements. It is practiced as a combination of body movements, breath control, and mindful meditation, which is designed to improve qi function. | Behavioural | Qigong |
| Light flexibility exerciseEach session will include seated and standing stretches that target upper (neck, arms, upper back, shoulders, back, and chest) and lower body (quadriceps, hamstrings, calves, and hips), as well as trunk rotations. | Behavioural | Light flexibility exercise |
Primary outcome
Improvement in frailty status
Time frame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Participants' frailty status will be assessed using the Fried frailty criteria, which consists of 5 criteria: slowness , weakness , unintentional weight loss , exhaustion and low activity. Patients with no criteria are considered robust, patients with 1 or 2 criteria are considered pre-frail, and patients with ≥3 criteria are considered frail.
4 secondary outcomes
Improvement in frailty scores
Time frame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Physical performance
Time frame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Psychological well-being
Time frame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Health-related quality of life
Time frame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
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 28 May 2025.
- Individual participant dataSharing planned: Yes. Data will be available on reasonable request as decided by the principal investigator.
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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.
Denise Shuk Ting Cheung, PhD principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong Baduanjin and Light flexibility exercise in people with Cancer and Frailty, run by The University of Hong Kong 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 6 inclusion and 2 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 28 May 2025. 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?
Improvement in frailty status (time frame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention). 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 28 May 2025.