SleepNCT04119778
Improving Sleep in Lung Cancer Patients: A Trial of Aerobic Exercise and Tai-chi
A study testing Aerobic Exercise, Tai chi in people with Sleep, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Lung cancer is one of the commonest cancers around the world. Sleep disturbances are commonly reported by lung cancer patients. Meanwhile, disturbed sleep is associated with several health problems, including shortened survival period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep
- What is being tested?
- Aerobic Exercise, Tai chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2019to 15 Sep 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed of stage IIIB, or IV non-small-cell lung cancer confirmed by pathology
- Patients are not currently engaged in other research or participant in any other exercise or mind-body classes
- Patients aged 18 years old, or above
- Patients who can communicate in Cantonese, Mandarin
- Patients with no other cancer diagnosis within the previous 1 year
- Patients report not doing regular exercises (defined <150 min of moderate-intensity exercise weekly) in daily living, but are able to attend either exercise or tai-chi classes at scheduled times
Show all 9Show fewer
- Patients with ECOG 0-1
- Patients being conscious and alert.
- Patients who can read and write in Chinese
Who cannot join
- Patients suffering from a diagnosed active neurological, substance abuse and /or psychiatric disorders (i.e. depression, chronic insomnia)。
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Sleep in Lung Cancer Patients: A Randomized Controlled Trial of Aerobic Exercise and Tai-chi Interventions
Lung cancer is one of the commonest cancers around the world. Sleep disturbances are commonly reported by lung cancer patients. Meanwhile, disturbed sleep is associated with several health problems, including shortened survival period. Thus, lung cancer imposes a substantial health burden on patients and society both locally and world widely. On top of the classical clinical therapies, additional approaches that could result in improved sleep are needed.
Previous studies, including our own, have shown that physical exercise, such as aerobic walking, improves lung cancer patient's physical fitness particularly cardiovascular fitness, circadian rhythm and immune function. Another popular mode of exercise in Chinese population is tai-chi. With emphasis on breathing and concentration, tai-chi exhibits extra benefits for stress-relieving and psychological well-being. Those benefits of exercise have long been implicated for better sleep of cancer patients. The promising benefits of aerobic exercise or tai-chi, as non-pharmacological interventions, urge for need of rigorous evidence on the effectiveness of these interventions in improving sleep outcomes. However, to date, there has been no report from a randomized controlled trial (RCT) to study the effect of aerobic exercise or tai-chi on sleep of lung cancer patients.
Read more
This proposed research is designed to conduct a three-arm RCT comparing aerobic exercise, tai-chi to usual care in non-small cell lung cancer patients. Recruited participants will be randomised into three groups: 1) a 16-week aerobic exercise group, 2) a 16-week tai-chi program group, and 3) a self-management control group. Aerobic exercise and tai-chi program will be conducted by certificated coaches. Life-long adherence to the practice in intervention groups is encouraged.
Through this project, the investigators aim to evaluate if 1) aerobic exercise or 2) tai-chi intervention promote subjective sleep quality in lung cancer patients compared to control, as the primary outcome of this study. The investigators shall also examine if tai-chi practice can provide similar improvement in sleep quality compared with ordinary exercise. Using biomarkers including circadian rhythm, cardio-respiratory fitness, further provides objective measures for bio-physiological effectiveness of the interventions. The associations of those biological measures and psycho-social status with sleep outcomes will be further explored.
Findings of this study will provide crucial information on the evidence-based practice by physical exercise or tai-chi to improve sleep of lung cancer patients. This study will also have far-reaching significance in providing important scientific evidence to policymakers to integrate physical activity into routine clinical management as an add-on treatment for lung cancer patients in Hong Kong.
- Conditions
- Sleep
- Being tested
- Aerobic Exercise, Tai chi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise, Tai chiBehavioural
They are aerobic and mind-body exercise respectively.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | The exercise intervention will last 16 weeks, comprised of home-based exercise with weekly telephone counselling to encourage participants to continue to exercise, supplemented with 8 supervised exercise sessions (2 sessions per month). Each session will last for an hour. The supervised exercise sessions will be provided by professional exercise specialists twice in the first week in each month throughout the intervention period, an hour each time. Exercise trainers will lead the classes. Each class will include both aerobic exercise and resistance exercise. They are encouraged to do aerobic exercise for at least 150 min weekly at a moderate intensity level, as well as perform resistance exercises alternate day. Participants are also provided an exercise diary, containing details of their weekly prescribed exercises and the scales they have to refer to. Receives: Behavioral: Aerobic Exercise, Tai chi |
| Tai chi | Experimental | Our tai-chi classes will be based on a 16-form tai-chi exercise set. The classes will run twice a week for 16 weeks with each session lasting approximately 60 minutes. Classes will be taught by an experienced tai-chi master, who will explain the theory behind tai-chi and the principles of the techniques. The supervised session includes a warm up, self-massage and a guided run through of the movements, breathing techniques, and relaxation in tai-chi. The tai-chi master will guide participants to practice the tai-chi they learn in the classes at home each day. Upon completion of the 16 weeks course, participants will be encouraged to continue their tai-chi practice, given guidance on local services and programmes they may join if they wish to. Receives: Behavioral: Aerobic Exercise, Tai chi |
| Self Management Group | No intervention | Participants randomised to the control group shall receive written information on health levels of physical activity, which they can participate in at home (self-management) and continue to receive their usual care, participants will be followed up with an assessment at 16 weeks and one year. At the end of the evaluation stage of the study, survivors in the control group will be invited to take part in an intervention of their choice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Sleep (Subjective)- Pittsburgh Sleep Quality Index
To assess the change of quality of sleep, the Chinese version of the Pittsburgh Sleep Quality Index, from baseline at 16-week and 1 year
Measured: 1 year
Secondary outcomes (16)
Levels of physical activity
To measure compliance to exercise all participants will be measured for their level of physical activity in daily living. Physical activity will be quantified with a non-invasive small-size wrist-worn piezoelectric accelerometer (Actigraph; Ambulatory Monitoring Inc., New York). Actigraphy has been shown to provide valid assessments of physical activity. The user-defined time interval for the count of wrist accelerations is 1 min. Patients will be asked to wear the actigraph for at least 3 consecutive 24-hour spans. Each patient will keep a diary for times of rising and retiring.
Measured: Baseline, 16-week, 1 year
Circadian rhythms- cortisol rhythms
We will measure circadian rhythms using biomarkers that have been linked to survival of cancer patients, cortisol rhythms will be measured using saliva samples collected before and after intervention. The cortisol levels will be measured using enzyme-linked immunosorbent assay (ELISA) kits. The saliva will be collected using Salivettes at following time points: 0.5 hour, 4 hour, 8 hour and 12 hour after habitual wake time (referred as circadian time).
Measured: Baseline, and 1 year
Circadian rhythms- melatonin rhythms
We will measure circadian rhythms using biomarkers that have been linked to survival of cancer patients, melatonin rhythms will be measured using saliva samples collected before and after intervention. The melatonin levels will be measured using enzyme-linked immunosorbent assay (ELISA) kits. The saliva will be collected using Salivettes at following time points: 0.5 hour, 4 hour, 8 hour and 12 hour after habitual wake time (referred as circadian time).
Measured: Baseline, and 1 year
Cardio-respiratory fitness- 6-minute walking test
Cardio-respiratory fitness shall be evaluated using the 6-minute walking test (6MWT). The 6MWT has been widely used to assess cardio-respiratory fitness in lung cancer patients [28-30]. The 6MWT requires participants to walk on an even and flat surface between two cones set 30m apart, with the object being the participant walking as far as possible within the 6 minutes period (if participant cannot continue for the 6 minutes, the test will end). The walking test is measured in units of meters walked at the end of the 6 minutes.
Measured: Baseline, 16-week, 1 year
Physical functioning- Get Active Questionnaire
Physical fitness will a be assessed using the Get Active Questionnaire (GAQ). The GAQ assesses if participants are safe to participate in the interventions and ensures if participants can perform the exercises within the intervention.
Measured: Baseline, 16-week, 1 year
Physical functioning- timed up and go test
This test evaluates participants' agility.
Measured: Baseline, 16-week, 1 year
Physical functioning-sit to stand test
This test evaluates participants' muscle strength.
Measured: Baseline, 16-week, 1 year
Physical functioning- single leg standing test
This test evaluates participants' balance.
Measured: Baseline, 16-week, 1 year
Immune functions- cytotoxic activity of natural killer (NK) cells, and spontaneous or phytohemagglutinin (PHA)-stimulated T-lymphocyte proliferation
For each participant, 10 ml of peripheral blood will be collected before and after intervention in intervention groups, as well as in control group at the same time points, for some immune functional studies. The peripheral blood mononuclear cells are isolated for measurements of immune functions. Immune functions will be analyzed by cytotoxic activity of natural killer (NK) cells, and spontaneous or phytohemagglutinin (PHA)-stimulated T-lymphocyte proliferation.
Measured: Baseline, 1 year
Health-related quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire
Health related QoL is an important outcome for lung cancer patients and plays an important impact on prognosis. The Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). It will be evaluated by three parts, global score, symptom score and functional score with the range of 0-100. Higher score in global and functional aspects denote better quality of life while lower score in symptom aspects denotes better quality of life.
Measured: Baseline, 16-week, 1 year
Health-related quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Core corresponding lung cancer-specific module
Health related QoL is an important outcome for lung cancer patients and plays an important impact on prognosis. The Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire corresponding lung cancer-specific module (QLQ-LC13) shall be used as measurements of QoL. Lower score denotes better quality of life. The range of score is 0-100.
Measured: Baseline, 16-week, 1 year
Psychological Distress- Hospital Anxiety and Depression Score
To evaluate psychological distress the Hospital Anxiety and Depression Score (HADS) will be used. The HADS comprises seven items each for anxiety and depression. Each item of the anxiety subscale and the depression subscale was scored on a 4-point scale. This scale is a reliable tool, and is widely used to assess patients with cancer.
Measured: Baseline, 16-week, 1 year
Fatigue- Brief Fatigue Inventory
Fatigue will be measured by the Chinese version of the Brief Fatigue Inventory (BFI). The BFI was developed to measure fatigue in cancer patients. It consists of 9 items with each item scored on a 0-10 scale. The BFI measures patients' fatigue when symptoms are at their worst, least, usual and currently during the normal waking hours, with 0 indicating no fatigue, and 10 being fatigue as bad as one can imagine. Other items include fatigues interaction with patients' general activity, mood, waking ability, normal work (includes both work outside the home and housework), relations with other people, ability to think clearly, and enjoyment of life. The interference is measured with 0 being does not interfere, and 10 being completely interferes.
Measured: Baseline, 16-week, 1 year
Quality of Sleep (Objective)- Actigraph
Actigraph will serve as an objective measure for assessing sleep parameters, such as sleep efficiency, total sleep time.
Measured: Baseline, 16-week, 1 year
Fried frailty Criteria
Frailty will be measured by weight loss, exhaustion, low physical activity, slowness and weakness.
Measured: Baseline, 16-week, 1 year
One-year survival rate
One-year relative survival rate will be retrieved from patients' medical record.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Apr 2019
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, 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, Professor Chia-Chin Lin, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119778
- Sponsor's protocol ID
- UW18154，
- Other IDs
- HKECCREC-2019-014, KC/KE-19-0039/ER-3
- Status last verified
- Mar 2023
- First submitted
- 6 Sep 2019
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Takemura N, Cheung DST, Fong DYT, Lee AWM, Lam TC, Ho JC, Kam TY, Chik JYK, Lin CC. Comparative effect of Tai Chi and aerobic exercise on cognitive function in advanced lung cancer survivors with perceived cognitive impairment: a three-arm randomized controlled trial with mediation analysis. J Cancer Surviv. 2025 Dec;19(6):1938-1947. doi: 10.1007/s11764-024-01607-1. Epub 2024 May 1.
PubMed 38691272Takemura N, Cheung DST, Fong DYT, Lee AWM, Lam TC, Ho JC, Kam TY, Chik JYK, Lin CC. Effectiveness of Aerobic Exercise and Tai Chi Interventions on Sleep Quality in Patients With Advanced Lung Cancer: A Randomized Clinical Trial. JAMA Oncol. 2024 Feb 1;10(2):176-184. doi: 10.1001/jamaoncol.2023.5248.
PubMed 38060250Takemura N, Cheung DST, Fong DYT, Lee AWM, Lam TC, Ho JC, Kam TY, Chik JYK, Lin CC. Relationship of subjective and objective sleep measures with physical performance in advanced-stage lung cancer patients. Sci Rep. 2021 Aug 26;11(1):17208. doi: 10.1038/s41598-021-96481-7.
PubMed 34446756
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep in Lung Cancer Patients: A Randomized Controlled Trial of Aerobic Exercise and Tai-chi Interventions
- ClinicalTrials.gov ID
- NCT04119778
- Acronym / sponsor ID
- UW18154，
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 8 Oct 2019 (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.
Lung cancer is one of the commonest cancers around the world. Sleep disturbances are commonly reported by lung cancer patients. Meanwhile, disturbed sleep is associated with several health problems, including shortened survival period. Thus, lung cancer imposes a substantial health burden on patients and society both locally and world widely. On top of the classical clinical therapies, additional approaches that could result in improved sleep are needed.
Previous studies, including our own, have shown that physical exercise, such as aerobic walking, improves lung cancer patient's physical fitness particularly cardiovascular fitness, circadian rhythm and immune function. Another popular mode of exercise in Chinese population is tai-chi. With emphasis on breathing and concentration, tai-chi exhibits extra benefits for stress-relieving and psychological well-being. Those benefits of exercise have long been implicated for better sleep of cancer patients. The promising benefits of aerobic exercise or tai-chi, as non-pharmacological interventions, urge for need of rigorous evidence on the effectiveness of these interventions in improving sleep outcomes. However, to date, there has been no report from a randomized controlled trial (RCT) to study the effect of aerobic exercise or tai-chi on sleep of lung cancer patients.
This proposed research is designed to conduct a three-arm RCT comparing aerobic exercise, tai-chi to usual care in non-small cell lung cancer patients. Recruited participants will be randomised into three groups: 1) a 16-week aerobic exercise group, 2) a 16-week tai-chi program group, and 3) a self-management control group. Aerobic exercise and tai-chi program will be conducted by certificated coaches. Life-long adherence to the practice in intervention groups is encouraged.
Through this project, the investigators aim to evaluate if 1) aerobic exercise or 2) tai-chi intervention promote subjective sleep quality in lung cancer patients compared to control, as the primary outcome of this study. The investigators shall also examine if tai-chi practice can provide similar improvement in sleep quality compared with ordinary exercise. Using biomarkers including circadian rhythm, cardio-respiratory fitness, further provides objective measures for bio-physiological effectiveness of the interventions. The associations of those biological measures and psycho-social status with sleep outcomes will be further explored.
Findings of this study will provide crucial information on the evidence-based practice by physical exercise or tai-chi to improve sleep of lung cancer patients. This study will also have far-reaching significance in providing important scientific evidence to policymakers to integrate physical activity into routine clinical management as an add-on treatment for lung cancer patients in Hong Kong.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic Exercise, Tai chiThe exercise intervention will last 16 weeks, comprised of home-based exercise with weekly telephone counselling to encourage participants to continue to exercise, supplemented with 8 supervised exercise sessions (2 sessions per month). Each session will last for an hour. The supervised exercise sessions will be provided by professional exercise specialists twice in the first week in each month throughout the intervention period, an hour each time. Exercise trainers will lead the classes. Each class will include both aerobic exercise and resistance exercise. They are encouraged to do aerobic exercise for at least 150 min weekly at a moderate intensity level, as well as perform resistance exercises alternate day. Participants are also provided an exercise diary, containing details of their weekly prescribed exercises and the scales they have to refer to. |
| Tai chi | Experimental | Behavioral: Aerobic Exercise, Tai chiOur tai-chi classes will be based on a 16-form tai-chi exercise set. The classes will run twice a week for 16 weeks with each session lasting approximately 60 minutes. Classes will be taught by an experienced tai-chi master, who will explain the theory behind tai-chi and the principles of the techniques. The supervised session includes a warm up, self-massage and a guided run through of the movements, breathing techniques, and relaxation in tai-chi. The tai-chi master will guide participants to practice the tai-chi they learn in the classes at home each day. Upon completion of the 16 weeks course, participants will be encouraged to continue their tai-chi practice, given guidance on local services and programmes they may join if they wish to. |
| Self Management Group | No intervention | –Participants randomised to the control group shall receive written information on health levels of physical activity, which they can participate in at home (self-management) and continue to receive their usual care, participants will be followed up with an assessment at 16 weeks and one year. At the end of the evaluation stage of the study, survivors in the control group will be invited to take part in an intervention of their choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who are diagnosed of stage IIIB, or IV non-small-cell lung cancer confirmed by pathology
- Patients are not currently engaged in other research or participant in any other exercise or mind-body classes
- Patients aged 18 years old, or above
- Patients who can communicate in Cantonese, Mandarin
- Patients with no other cancer diagnosis within the previous 1 year
Key exclusion criteria (1 listed)
- Patients suffering from a diagnosed active neurological, substance abuse and /or psychiatric disorders (i.e. depression, chronic insomnia)。
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 |
|---|---|---|
| Aerobic Exercise, Tai chiThey are aerobic and mind-body exercise respectively. | Behavioural | Aerobic Exercise, Tai chi |
Primary outcome
Quality of Sleep (Subjective)- Pittsburgh Sleep Quality Index
Time frame: 1 year
To assess the change of quality of sleep, the Chinese version of the Pittsburgh Sleep Quality Index, from baseline at 16-week and 1 year
16 secondary outcomes
Levels of physical activity
Time frame: Baseline, 16-week, 1 year
Circadian rhythms- cortisol rhythms
Time frame: Baseline, and 1 year
Circadian rhythms- melatonin rhythms
Time frame: Baseline, and 1 year
Cardio-respiratory fitness- 6-minute walking test
Time frame: Baseline, 16-week, 1 year
Physical functioning- Get Active Questionnaire
Time frame: Baseline, 16-week, 1 year
Physical functioning- timed up and go test
Time frame: Baseline, 16-week, 1 year
Physical functioning-sit to stand test
Time frame: Baseline, 16-week, 1 year
Physical functioning- single leg standing test
Time frame: Baseline, 16-week, 1 year
Immune functions- cytotoxic activity of natural killer (NK) cells, and spontaneous or phytohemagglutinin (PHA)-stimulated T-lymphocyte proliferation
Time frame: Baseline, 1 year
Health-related quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire
Time frame: Baseline, 16-week, 1 year
Health-related quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Core corresponding lung cancer-specific module
Time frame: Baseline, 16-week, 1 year
Psychological Distress- Hospital Anxiety and Depression Score
Time frame: Baseline, 16-week, 1 year
Fatigue- Brief Fatigue Inventory
Time frame: Baseline, 16-week, 1 year
Quality of Sleep (Objective)- Actigraph
Time frame: Baseline, 16-week, 1 year
Fried frailty Criteria
Time frame: Baseline, 16-week, 1 year
One-year survival rate
Time frame: 1 year
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 14 Mar 2023.
- Derived from this study: PubMed 38691272Takemura N, Cheung DST, Fong DYT, Lee AWM, Lam TC, Ho JC, Kam TY, Chik JYK, Lin CC. Comparative effect of Tai Chi and aerobic exercise on cognitive function in advanced lung cancer survivors with perceived cognitive impairment: a three-arm randomized controlled trial with mediation analysis. J Cancer Surviv. 2025 Dec;19(6):1938-1947. doi: 10.1007/s11764-024-01607-1. Epub 2024 May 1.
- Derived from this study: PubMed 38060250Takemura N, Cheung DST, Fong DYT, Lee AWM, Lam TC, Ho JC, Kam TY, Chik JYK, Lin CC. Effectiveness of Aerobic Exercise and Tai Chi Interventions on Sleep Quality in Patients With Advanced Lung Cancer: A Randomized Clinical Trial. JAMA Oncol. 2024 Feb 1;10(2):176-184. doi: 10.1001/jamaoncol.2023.5248.
- Derived from this study: PubMed 34446756Takemura N, Cheung DST, Fong DYT, Lee AWM, Lam TC, Ho JC, Kam TY, Chik JYK, Lin CC. Relationship of subjective and objective sleep measures with physical performance in advanced-stage lung cancer patients. Sci Rep. 2021 Aug 26;11(1):17208. doi: 10.1038/s41598-021-96481-7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Tai chi in people with Sleep, run by The University of Hong Kong at 1 site 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 9 inclusion and 1 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Quality of Sleep (Subjective)- Pittsburgh Sleep Quality Index (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04119778, which also lists 3 linked publications.
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 14 Mar 2023.