A Study on Effects of Acupressure Among the Frail Elderly in the Community Dwellings

NCT02369094 | Completed DMC

• 1 other identifier: CTC1215
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Acupressure has been used for thousands of years in China. Through applying pressure on the specific acupoints based on TCM 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, HKU. 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.\[1\] 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 our 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.

Conditions

Impaired

Keywords

Frailty; Frail elderly; Acupressure; Pragmatic Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Elderlies' Quality of Life

  Questionnaires: 1. General QOL: WHOQOL-BREF, Interview Version for Hong Kong Chinese(28 Items)\[2\] 2. Psychosocial function: Geriatric Depression Scale SF(15 Items)\[4\] 3. Sleeping quality: PSQI(9 Items)\[5\] Physiological aspect: Electronic sphygmomanometer:Blood pressure and Heart rate

  Time Frame: Baseline, change from baseline at 3rd month, change from baseline at 6th month

Secondary Outcomes (1)

• Caregiver Stress Level Modified Care givers Strain Index(13 items)[6]; Perceived burden level scale （1 item）

  Time Frame: Baseline, change from baseline at 3rd month, change from baseline at 6th month

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 centers. The caregiver 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

Waiting Control Group

OTHER

No acupressure therapy will be provided during the 1st 12 weeks' of study.The enrolled elderly will join a group activity, resembling the other group activities that held in that particular center, their caregivers will be requested to spend two 20 minutes sessions per week with the elderly doing homework assigned by the activity group and log down the timing in the log book.This arrangement is to account for the placebo effect of additional social interaction time and attention that the treatment group will receive during this period. After completing the 1st 12 weeks' participation in the Waiting Control Group, the subject dyads in the waiting control group will receive the same training and treatment as the treatment group.

Other: acupressure

Interventions

acupressure OTHER

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 centers. The caregiver 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; Waiting Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Elderly:
• Age: over 65 years old;
• Gender: male or female;
• Currently is a client served by the identified centers of YCHSS;
• Demonstrate frailty : score 5 or more in the Tilburg Frailty Indicator (TFI );
• Able to enroll in patient-caregiver dyad (i.e. have a capable designated caregiver enroll in the trial). The caregiver is preferred to be a family member, but could also be a close friend or helper, as long as the designated person spends time regularly with the frail elderly;
• Physically fit to sit on a normal chair for 15-20 mins for acupressure treatment;
• Cognitively competent to understand the instruction from the practitioner and participate actively in the control group activity (resembling other art and craft activities offered by center);
• Cognitively competent to sign the consent form: score 6 or more in Abbreviated Mental Test (AMT, Hong Kong Version);
• Signed the Patient/Subject Consent Form for this study.
• Caregiver:
• Family member, paid/informal helper or friend of the qualified elderly who will meet with the elderly on a weekly basis;
• Committed to learn the acupressure protocol and practice the protocol on the elderly twice a week, during the 12-weeks study period, and support the control group activities (if applicable);
• Cognitively competent to sign the consent form (for caregiver age 65 or above): score 6 or more in Abbreviated Mental Test (AMT, Hong Kong Version,);
• Signed the Patient/Subject Consent Form for this study.

You may not qualify if:

• Elderly in the following situation will be excluded from the study:
• Who is currently receiving acupressure as a regular therapy;
• Who is decision impaired and unfit to sign the consent form;
• 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);
• Who is unable to comply to the set treatment schedule (20% non compliance is allowed).
• Caregiver in the following situation will be excluded from the study:
• Who do not complete the training or incapable to reach a set standard of performing the acupressure protocol;
• Who is decision impaired and unfit to sign the consent form.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Yan Chai Hospital: collaborator

Study Sites (1)

School of Chinese Medicine, The University of Hong Kong

Hong Kong, Hong Kong, 852, China

Location

Related Publications (4)

• 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: 15382991 BACKGROUND

• Hankins M. The reliability of the twelve-item general health questionnaire (GHQ-12) under realistic assumptions. BMC Public Health. 2008 Oct 14;8:355. doi: 10.1186/1471-2458-8-355.

  PMID: 18854015 BACKGROUND

• SHEIKH JI, YESAVAGE JA. Geriatric Depression Scale (GDS): recent evidence and development of a shorter version. Clin Gerontol . 1986 June;5(1/2):165-173.

  BACKGROUND

• 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: 2748771 BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

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: February 4, 2015
• First Posted: February 23, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

CN (1)