NCT02491216

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

June 11, 2015

Last Update Submit

May 10, 2016

Conditions

Keywords

FrailtyFrail elderlyAcupressurePragmatic Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 12 weeks, 6th months

Secondary Outcomes (3)

  • change of sleeping quality

    Baseline, 12 weeks, 6th months

  • change of blood pressure

    Baseline, 12 weeks, 6th months

  • change of heart rate

    Baseline, 12 weeks, 6th months

Study Arms (2)

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.

Other: Acupressure

Control Group

NO INTERVENTION

No acupressure therapy will be provided during the study.

Interventions

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.

Also known as: Tui-na
Acupressure Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Chinese Medicine, The University of Hong Kong

Hong Kong, Hong Kong, 852, China

Location

Related Publications (8)

  • 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.

    PMID: 21531533BACKGROUND
  • Department of Economic and Social Affairs Population Division, United Nations. World Population Aging: 1950-2050. United Nation Publication, 2001.

    BACKGROUND
  • 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.

    PMID: 15382991BACKGROUND
  • Gobbens 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.

    PMID: 20511102BACKGROUND
  • Pialoux 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.

    PMID: 22233158BACKGROUND
  • Chu 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
  • 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.

    PMID: 15892443BACKGROUND
  • Buysse 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.

    PMID: 2748771BACKGROUND

Related Links

MeSH Terms

Conditions

Frailty

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Lei Li

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

July 7, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations