ImpairedNCT02491216
A Study on Effects of Acupressure Among the Frail Elderly in Residential Care Services for the Elderly
A study testing Acupressure in people with Impaired, run by The University of Hong Kong at 1 site in China.
Trial summary
Acupressure has been used for thousands of years in China. Through applying pressure on the specific acupoints based on Traditional Chinese Medicine theory, acupressure could promote relaxation and wellness, balance yin-yang and treat diseases. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Impaired
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Mar 2016
- 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
- a. Age: 65 years and older;
- b. Gender: male or female;
- c. Currently is a client served by the Residential Care services of YCHSS;
- d. Demonstrate frailty: score 5 or more in the Tilburg Frailty Indicator (TFI);
- e. Physically fit to sit on a normal chair for 15-20 mins for acupressure treatment;
- f. Cognitively competent to understand the instruction from the practitioner and participate actively in the exercise program offered by the Residential Care of YCHSS);
- g. Cognitively competent to sign the consent form: score 6 or more in Abbreviated Mental Test (AMT, Hong Kong Version);
- h. Signed the Patient/Subject Consent Form for this study.
Who cannot join
- a. Who is currently receiving acupressure or acupuncture as a regular therapy;
- b. Who is decision impaired and unfit to sign the consent form;
- c. Who is suffering from one of the related contraindications for acupressure (including open sores; undiagnosed rashes; high fever; hypertensive emergence; sore and enlarged lymph nodes; the site of an injury, surgery or injection; burn wounds; skin ulcers and eczema);
- d. Who is unable to comply to the set treatment schedule (20% non compliance is allowed).
Trial locations and contacts
1 site in 1 country.
China1 site
School of Chinese Medicine, The University of Hong Kong
Hong Kong, Hong Kong, 852
About this study
Official title: A Study on Effects of Acupressure Among the Frail Elderly in Homes for the Aged and Care and Attention Homes for the Elderly
Acupressure has been used for thousands of years in China. Through applying pressure on the specific acupoints based on Traditional Chinese Medicine theory, acupressure could promote relaxation and wellness, balance yin-yang and treat diseases.
The PI has been using acupressure to treat various diseases in the clinics of the School of Chinese Medicine, The University of Hong Kong. Acupressure has demonstrated significant efficacy in treating geriatric diseases, obstetric diseases, pediatric diseases, rheumatoid arthritis and various painful symptoms. When applying acupressure on the Head- Neck - Shoulder area, it could also help to improve insomnia, reduce pain, and regulate the mood of the patients.
"Frailty" is a geriatric syndrome of growing importance in the medical field. Prevalence of frailty increases with age. As our life expectancy increase, there will be more elderly suffered from frailty in the later stage of their life. Although there is still a lack of universally accepted clinical definition for frailty, the syndrome is now commonly understood as decreased reserves in multiple systems, and lowered resilience to negative stress. Frailty could be initiated by single or multiple conditions including malnutrition, chronic diseases, lack of exercise, stress and physiological or social changes caused by aging. Its manifestation includes sarcopenia, anorexia, energy reduction, dysfunctional neuroendocrine system and a pro-inflammatory state. Frailty could affect the emotional state of the elderly, meanwhile, positive affect is protective against the functional and physical decline associated with frailty. There is limited treatment or medication for frailty. The investigators believe that acupressure could be a possible non invasive means to improve the general health conditions, including the emotional conditions of the frail elderly. In the past 2 years, the school of Chinese Medicine has been promoting acupressure as a health maintenance technique to the elderly, mostly frail elderly living in the community dwelling through seminars. It is in investigator's interest to run a prospective research to further understand the efficacy of acupressure in a wider range of frail elderly. The investigators would like to use a well-designed pragmatic randomized controlled trial (PRCT) to investigate if acupressure could help the frail elderly to improve their general quality of life
Read the detailed description
The research is a collaborative project by The University of Hong Kong and Yan Chai Hospital, with the aim of investigating the potential benefits of applying acupressure regularly on frail elderly. The study is designed as a prospective randomized control trial with the primary objective to investigate if acupressure could help the elderlies to improve their general quality of life.
"Frailty" is a geriatric syndrome of growing importance in the medical field. Although there is still a lack of universally accepted clinical definition for frailty, the syndrome is now commonly understood as decreased reserves in multiple systems, and lowered resilience to negative stress. Frailty could affect the emotional state of the elderlies; meanwhile, positive affect is protective against the functional and physical decline associated with frailty. Since there is limited treatment or medication for frailty. The investigators would like to investigate if acupressure could be a possible non-invasive means to improve the general health conditions, including the psycho-social well being of the frail elderly.
The aim of this research is to study potential beneficial effects of acupressure on a group of frail elderly living in the Homes for the Aged and Care and Attention Homes for the Elderly.
In this study, the investigators will use Tilburg Frailty Indicator (TFI) to assess the frailty level of the elderly.
- Trial Design:
This is a multicenter, pragmatic randomized control trial (PRCT) with a prospective design.
Hypothesis:
- Applying regular acupressure (4 times a week, totally 12 weeks) on frail elderly in residential care will improve one or more of the following aspects:
- Elderly's quality of life
- Elderly's sleeping quality
- Elderly's Blood pressure/heart rate
- Regular acupressure provides additional benefit to the frail elderly in residential care on top of their regular exercise program 108 frail elderlies currently served by the Homes for the Aged and Care and Attention Homes for the Elderly of the Yan Chai Hospital, Social Services Department (YCHSS) will be recruited. All these elderlies are currently participating in the exercise program offered by the residential services of YCHSS. All applications will be screened by the para-medical staffs in the residential services based on the inclusion and exclusion criteria. Qualified applicants will be invited for a health assessment conducted by registered Traditional Chinese Medicine practitioner in the research team to confirm their suitability and invite them to sign the consent form. The consented elderlies will be allocated randomly into treatment group and control group. Randomization is done by computer generated number list in block of 4.
II. Intervention The enrolled elderly will participate in all the assessments and continue to participate in the exercise program offered by the residential care of YCHSS.
Acupressure Group:
A 15 minutes structured acupressure protocol with specific acupoints and applications technique will be performed on the elderly participants twice a week by the research team in YCHSS Homes. Designated para-medical staffs working in the elderly home or informal care giver of the elderly will be trained and perform the same acupressure protocol on the elderly at 2 additional occasions during the week. The total trial period is 12 weeks.
The acupressure treatment involved 12 steps, and mainly concentrates on the acupoints on face, head, neck and shoulder. The treatment is designed to be operated by layman. The acupoints chosen are all easy to be located. All the movements/steps selected are well established and commonly used in the Traditional Chinese Medicine practices. Any movement that demand professional training or involve potential risk (e.g. joint mobilization) is excluded from the protocol. The total treatment process will last for approximately 15 mins.
All the elderly will be invited to participate in a lecture of health care in Chinese medicine after the research.
Control group:
No acupressure therapy will be provided during the study. All the elderly will be invited to participate in a lecture of health care in Chinese medicine after the research.
III. Assessment of Efficacy Efficacy of the treatments will be measured in multi dimensions before and after the treatment for both groups. Time Frame of the assessment are: (1) Baseline; (2) Change from baseline after 12 weeks; (3) Change from baseline at 6th month. The primary outcomes will be the change in quality of life of the frail elderly. The secondary outcomes will be sleeping quality and physiological aspects of the frail elderly. All instruments employed are international recognized and provide an absolute score in measurement.
- Conditions
- Impaired
- Being tested
- Acupressure
- Keywords
- Frailty, Frail elderly, Acupressure, Pragmatic Randomised Controlled Trial
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Also called Tui-na
A 15 minutes structured acupressure protocol with specific acupoints and applications technique will be performed on the elderly participants twice a week by the research team in YCHSS Homes. Designated para-medical staffs working in the elderly home or informal care giver of the elderly will be trained and perform the same acupressure protocol on the elderly at 2 additional occasions during the week. The total trial period is 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Group | Experimental | A 15 minutes structured acupressure protocol with specific acupoints and applications technique will be performed on the elderly participants twice a week by the research team in YCHSS Homes. Designated para-medical staffs working in the elderly home or informal care giver of the elderly will be trained and perform the same acupressure protocol on the elderly at 2 additional occasions during the week. The total trial period is 12 weeks. Receives: Other: Acupressure |
| Control Group | No intervention | No acupressure therapy will be provided during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of quality of life
questionnaire: Short Form 12 questions Health Survey version 2 (SF-12,v2), Version for Hong Kong Chinese will be used to measure the quality of life of the elderly pre-treatment and post treatment.
Measured: Baseline, 12 weeks, 6th months
Secondary outcomes (3)
change of sleeping quality
questionnaire: Pittsburgh Sleep Quality Index (PSQI) will be used to assess the change in sleeping quality of the frail elderly pre-treatment and post treatment.
Measured: Baseline, 12 weeks, 6th months
change of blood pressure
Sphygmomanometer：Record of the blood pressure of the frail elderly will be logged pre- treatment and during the 12 weeks treatment period on a weekly basis.
Measured: Baseline, 12 weeks, 6th months
change of heart rate
Sphygmomanometer：Record of the heart rate of the frail elderly will be logged pre- treatment and during the 12 weeks treatment period on a weekly basis.
Measured: Baseline, 12 weeks, 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ImpairedStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Yan Chai Hospital
- Responsible party
- Sponsor
- Investigators
- Lei Li, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491216
- Sponsor's protocol ID
- CTC1215-2
- Status last verified
- May 2016
- First submitted
- 11 Jun 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lee EJ, Frazier SK. The efficacy of acupressure for symptom management: a systematic review. J Pain Symptom Manage. 2011 Oct;42(4):589-603. doi: 10.1016/j.jpainsymman.2011.01.007. Epub 2011 Apr 30.
PubMed 21531533Department of Economic and Social Affairs Population Division, United Nations. World Population Aging: 1950-2050. United Nation Publication, 2001.
Ostir GV, Ottenbacher KJ, Markides KS. Onset of frailty in older adults and the protective role of positive affect. Psychol Aging. 2004 Sep;19(3):402-8. doi: 10.1037/0882-7974.19.3.402.
PubMed 15382991Gobbens RJ, van Assen MA, Luijkx KG, Wijnen-Sponselee MT, Schols JM. The Tilburg Frailty Indicator: psychometric properties. J Am Med Dir Assoc. 2010 Jun;11(5):344-55. doi: 10.1016/j.jamda.2009.11.003. Epub 2010 May 8.
PubMed 20511102Pialoux T, Goyard J, Lesourd B. Screening tools for frailty in primary health care: a systematic review. Geriatr Gerontol Int. 2012 Apr;12(2):189-97. doi: 10.1111/j.1447-0594.2011.00797.x. Epub 2012 Jan 10.
PubMed 22233158Chu LW, Pei CKW, HoMH et al. Validation of the Abbreviated Mental Test (Hong Kong version) in the elderly medical patient. Hong Kong Med J 1995;1:207-211.
Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005 Mar;14(2):539-47. doi: 10.1007/s11136-004-0704-3.
PubMed 15892443Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Effects of Acupressure Among the Frail Elderly in Homes for the Aged and Care and Attention Homes for the Elderly
- ClinicalTrials.gov ID
- NCT02491216
- Acronym / sponsor ID
- CTC1215-2
- Conditions
- Impaired
- Keywords
- Frailty, Frail elderly, Acupressure, Pragmatic Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Yan Chai Hospital
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Jul 2015 (estimated)
- 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.
Acupressure has been used for thousands of years in China. Through applying pressure on the specific acupoints based on Traditional Chinese Medicine theory, acupressure could promote relaxation and wellness, balance yin-yang and treat diseases.
The PI has been using acupressure to treat various diseases in the clinics of the School of Chinese Medicine, The University of Hong Kong. Acupressure has demonstrated significant efficacy in treating geriatric diseases, obstetric diseases, pediatric diseases, rheumatoid arthritis and various painful symptoms. When applying acupressure on the Head- Neck - Shoulder area, it could also help to improve insomnia, reduce pain, and regulate the mood of the patients.
"Frailty" is a geriatric syndrome of growing importance in the medical field. Prevalence of frailty increases with age. As our life expectancy increase, there will be more elderly suffered from frailty in the later stage of their life. Although there is still a lack of universally accepted clinical definition for frailty, the syndrome is now commonly understood as decreased reserves in multiple systems, and lowered resilience to negative stress. Frailty could be initiated by single or multiple conditions including malnutrition, chronic diseases, lack of exercise, stress and physiological or social changes caused by aging. Its manifestation includes sarcopenia, anorexia, energy reduction, dysfunctional neuroendocrine system and a pro-inflammatory state. Frailty could affect the emotional state of the elderly, meanwhile, positive affect is protective against the functional and physical decline associated with frailty. There is limited treatment or medication for frailty. The investigators believe that acupressure could be a possible non invasive means to improve the general health conditions, including the emotional conditions of the frail elderly. In the past 2 years, the school of Chinese Medicine has been promoting acupressure as a health maintenance technique to the elderly, mostly frail elderly living in the community dwelling through seminars. It is in investigator's interest to run a prospective research to further understand the efficacy of acupressure in a wider range of frail elderly. The investigators would like to use a well-designed pragmatic randomized controlled trial (PRCT) to investigate if acupressure could help the frail elderly to improve their general quality of life
Detailed description
The research is a collaborative project by The University of Hong Kong and Yan Chai Hospital, with the aim of investigating the potential benefits of applying acupressure regularly on frail elderly. The study is designed as a prospective randomized control trial with the primary objective to investigate if acupressure could help the elderlies to improve their general quality of life.
"Frailty" is a geriatric syndrome of growing importance in the medical field. Although there is still a lack of universally accepted clinical definition for frailty, the syndrome is now commonly understood as decreased reserves in multiple systems, and lowered resilience to negative stress. Frailty could affect the emotional state of the elderlies; meanwhile, positive affect is protective against the functional and physical decline associated with frailty. Since there is limited treatment or medication for frailty. The investigators would like to investigate if acupressure could be a possible non-invasive means to improve the general health conditions, including the psycho-social well being of the frail elderly.
The aim of this research is to study potential beneficial effects of acupressure on a group of frail elderly living in the Homes for the Aged and Care and Attention Homes for the Elderly.
In this study, the investigators will use Tilburg Frailty Indicator (TFI) to assess the frailty level of the elderly.
- Trial Design:
This is a multicenter, pragmatic randomized control trial (PRCT) with a prospective design.
Hypothesis:
- Applying regular acupressure (4 times a week, totally 12 weeks) on frail elderly in residential care will improve one or more of the following aspects:
- Elderly's quality of life
- Elderly's sleeping quality
- Elderly's Blood pressure/heart rate
- Regular acupressure provides additional benefit to the frail elderly in residential care on top of their regular exercise program 108 frail elderlies currently served by the Homes for the Aged and Care and Attention Homes for the Elderly of the Yan Chai Hospital, Social Services Department (YCHSS) will be recruited. All these elderlies are currently participating in the exercise program offered by the residential services of YCHSS. All applications will be screened by the para-medical staffs in the residential services based on the inclusion and exclusion criteria. Qualified applicants will be invited for a health assessment conducted by registered Traditional Chinese Medicine practitioner in the research team to confirm their suitability and invite them to sign the consent form. The consented elderlies will be allocated randomly into treatment group and control group. Randomization is done by computer generated number list in block of 4.
II. Intervention The enrolled elderly will participate in all the assessments and continue to participate in the exercise program offered by the residential care of YCHSS.
Acupressure Group:
A 15 minutes structured acupressure protocol with specific acupoints and applications technique will be performed on the elderly participants twice a week by the research team in YCHSS Homes. Designated para-medical staffs working in the elderly home or informal care giver of the elderly will be trained and perform the same acupressure protocol on the elderly at 2 additional occasions during the week. The total trial period is 12 weeks.
The acupressure treatment involved 12 steps, and mainly concentrates on the acupoints on face, head, neck and shoulder. The treatment is designed to be operated by layman. The acupoints chosen are all easy to be located. All the movements/steps selected are well established and commonly used in the Traditional Chinese Medicine practices. Any movement that demand professional training or involve potential risk (e.g. joint mobilization) is excluded from the protocol. The total treatment process will last for approximately 15 mins.
All the elderly will be invited to participate in a lecture of health care in Chinese medicine after the research.
Control group:
No acupressure therapy will be provided during the study. All the elderly will be invited to participate in a lecture of health care in Chinese medicine after the research.
III. Assessment of Efficacy Efficacy of the treatments will be measured in multi dimensions before and after the treatment for both groups. Time Frame of the assessment are: (1) Baseline; (2) Change from baseline after 12 weeks; (3) Change from baseline at 6th month. The primary outcomes will be the change in quality of life of the frail elderly. The secondary outcomes will be sleeping quality and physiological aspects of the frail elderly. All instruments employed are international recognized and provide an absolute score in measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group | Experimental | Other: AcupressureA 15 minutes structured acupressure protocol with specific acupoints and applications technique will be performed on the elderly participants twice a week by the research team in YCHSS Homes. Designated para-medical staffs working in the elderly home or informal care giver of the elderly will be trained and perform the same acupressure protocol on the elderly at 2 additional occasions during the week. The total trial period is 12 weeks. |
| Control Group | No intervention | –No acupressure therapy will be provided during the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- a. Age: 65 years and older;
- b. Gender: male or female;
- c. Currently is a client served by the Residential Care services of YCHSS;
- d. Demonstrate frailty: score 5 or more in the Tilburg Frailty Indicator (TFI);
- e. Physically fit to sit on a normal chair for 15-20 mins for acupressure treatment;
Key exclusion criteria (4 listed)
- a. Who is currently receiving acupressure or acupuncture as a regular therapy;
- b. Who is decision impaired and unfit to sign the consent form;
- c. Who is suffering from one of the related contraindications for acupressure (including open sores; undiagnosed rashes; high fever; hypertensive emergence; sore and enlarged lymph nodes; the site of an injury, surgery or injection; burn wounds; skin ulcers and eczema);
- d. Who is unable to comply to the set treatment schedule (20% non compliance is allowed).
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 |
|---|---|---|
| AcupressureAlso: Tui-naA 15 minutes structured acupressure protocol with specific acupoints and applications technique will be performed on the elderly participants twice a week by the research team in YCHSS Homes. Designated para-medical staffs working in the elderly home or informal care giver of the elderly will be trained and perform the same acupressure protocol on the elderly at 2 additional occasions during the week. The total trial period is 12 weeks. | Other | Acupressure Group |
Primary outcome
Change of quality of life
Time frame: Baseline, 12 weeks, 6th months
questionnaire: Short Form 12 questions Health Survey version 2 (SF-12,v2), Version for Hong Kong Chinese will be used to measure the quality of life of the elderly pre-treatment and post treatment.
3 secondary outcomes
change of sleeping quality
Time frame: Baseline, 12 weeks, 6th months
change of blood pressure
Time frame: Baseline, 12 weeks, 6th months
change of heart rate
Time frame: Baseline, 12 weeks, 6th months
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 12 May 2016.
- Background: PubMed 21531533Lee EJ, Frazier SK. The efficacy of acupressure for symptom management: a systematic review. J Pain Symptom Manage. 2011 Oct;42(4):589-603. doi: 10.1016/j.jpainsymman.2011.01.007. Epub 2011 Apr 30.
- BackgroundDepartment of Economic and Social Affairs Population Division, United Nations. World Population Aging: 1950-2050. United Nation Publication, 2001.
- Background: PubMed 15382991Ostir GV, Ottenbacher KJ, Markides KS. Onset of frailty in older adults and the protective role of positive affect. Psychol Aging. 2004 Sep;19(3):402-8. doi: 10.1037/0882-7974.19.3.402.
- Background: PubMed 20511102Gobbens RJ, van Assen MA, Luijkx KG, Wijnen-Sponselee MT, Schols JM. The Tilburg Frailty Indicator: psychometric properties. J Am Med Dir Assoc. 2010 Jun;11(5):344-55. doi: 10.1016/j.jamda.2009.11.003. Epub 2010 May 8.
- Background: PubMed 22233158Pialoux T, Goyard J, Lesourd B. Screening tools for frailty in primary health care: a systematic review. Geriatr Gerontol Int. 2012 Apr;12(2):189-97. doi: 10.1111/j.1447-0594.2011.00797.x. Epub 2012 Jan 10.
- BackgroundChu LW, Pei CKW, HoMH et al. Validation of the Abbreviated Mental Test (Hong Kong version) in the elderly medical patient. Hong Kong Med J 1995;1:207-211.
- Background: PubMed 15892443Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005 Mar;14(2):539-47. doi: 10.1007/s11136-004-0704-3.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- The International Quality of Life Assessment (IQOLA) Project, which is in its tenth year, is translating, validating, and norming the SF-36 Health Survey for use in multinational clinical trials and other international studies.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Lei Li principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Impaired, run by The University of Hong Kong at 1 site in China.
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 8 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 12 May 2016. 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 China. 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?
Change of quality of life (time frame: Baseline, 12 weeks, 6th months). 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 NCT02491216, which also lists 8 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 12 May 2016.