NCT05009147

Brief Summary

The purpose of this study is to investigate the effects of manual massage on improving behavioral and psychological symptoms of dementia and sense of burden among caregivers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

August 8, 2021

Last Update Submit

April 6, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • change agitation

    Cohen-Mansfield Agitation Inventory (CMAI)

    before , during and after 8-weeks massage training interventions

  • change depression

    Cornell Scale for Depression in Dementia (CSDD)

    before , during and after 8-weeks massage training interventions

  • change stress

    Perceived Stress Scale(PSS)

    before , during and after 8-weeks massage training interventions

Study Arms (2)

experimental group

EXPERIMENTAL

receive whole body manual massage

Other: Home-based massage by caregivers for dementia

control group

NO INTERVENTION

After experiment, receive whole body manual massage

Interventions

A total of 40 patients with dementia and their family caregivers will be included and randomly allocated to experiment (n=20) or control group (n=20). The experiment and control group will receive whole body manual massage and placebo intervention (30 minutes once per week for 8 continuous weeks), respectively.

experimental group

Eligibility Criteria

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

You may qualify if:

  • Over 65 years old, diagnosed with dementia, agitation or depression, irregular massage and exercise habits.

You may not qualify if:

  • Those who have open wounds, inflammation, infection, burns and scalds, artificial blood vessels in the hands, or diagnosed as inappropriate for massage in the near future, the severity of symptoms affects the study participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 11219, Taiwan

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Chen-Yi Song

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 8, 2021

First Posted

August 17, 2021

Study Start

January 1, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

April 7, 2022

Record last verified: 2022-04

Locations