Clinical trial NCT02491216: A Study on Effects of Acupressure Among the Frail Elderly in Residential Care Services for the Elderly
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired
Keywords: Frailty
Frail elderly
Acupressure
Pragmatic Randomised Controlled Trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Yan Chai Hospital
First posted: 2015-07-07
Enrollment: 65
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

I. Trial Design:

This is a multicenter, pragmatic randomized control trial (PRCT) with a prospective design.

Hypothesis:

1. 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
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change of quality of life
timeFrame: Baseline, 12 weeks, 6th months
Secondary outcomes:
measure: change of sleeping quality
timeFrame: Baseline, 12 weeks, 6th months
measure: change of blood pressure
timeFrame: Baseline, 12 weeks, 6th months
measure: change of heart rate
timeFrame: Baseline, 12 weeks, 6th months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: School of Chinese Medicine, The University of Hong Kong
state: Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Lei Li
role: PRINCIPAL_INVESTIGATOR
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