A Randomized Controlled Trial on the Effect of Exercise on Physical, Cognitive and Affective Function in Dementia Subjects

July 6, 2010 updated by: Hospital Authority, Hong Kong

To Study the Effect of Exercise Training in Term of Aerobic Exercise for 3 Months, on the Physical, Cognitive and Affective Function in Dementia Subjects

Studies have shown conflicting results of the effect of exercise on dementia patients.

The aim of this study is to examine the role of physical activity on the risk of cognitive impairment and dementia in older persons.

To promote the benefits of aerobic exercise on dementia patients and encourage exercise prescription in the management of dementia subjects.

Study Overview

Status

Unknown

Conditions

Dementia

Intervention / Treatment

Procedure: Aerobic exercise training

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Hong Kong, China
    - Recruiting
    - Kwong Wah Hospital
    - Sub-Investigator:
      
      Ying Fai Mak, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

MMSE<26
Age >60
Community dwelling and ambulatory
Have a caregiver that is willing to participate and escort patient to hospital for training and assessment

Exclusion Criteria:

MMSE<10
live in old age home
poor mobility, unable to attend exercise training
no carer to bring patient to attend hospital training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical function measurement using SF-12 Time Frame: every 3 months for 1 year	every 3 months for 1 year
Affective function measurement by Cornell depression score Time Frame: every 3 months for 1 year	every 3 months for 1 year
Cognitive function by MMSE and ADAS-cog Time Frame: every 3 months for 1 year	every 3 months for 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
6 minutes walk, functional reach, Berg balance scale Time Frame: every 3 months for 1 year	every 3 months for 1 year
Carer stress scale Time Frame: every 3 months for 1 year	every 3 months for 1 year
No. of fall/restricted activity days/time spend in exercise or walking Time Frame: every 3 months for 1 year	every 3 months for 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Investigators

Principal Investigator: Doris KY Miu, Dr, Department of Medicine and Geriatrics, Kwong Wah Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

HAREC Clinical Trial Registry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Anticipated)

October 1, 2007

Study Registration Dates

First Submitted

July 6, 2007

First Submitted That Met QC Criteria