HAREC Clinical Trial Registry Record
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Title for Public A randomized controlled trial on the effect of exercise on physical, cognitive and affective function in dementia subjects
HAREC ID HARECCTR0500054
Scientific Title 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

Brief Summary 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.

Trial ID
HA REC Trial ID KW/EX05-090
Name of CREC KWC-CREC

Other Trial IDs
ID Number
Issuing Authority
 
Lead Principal Investigator
Name Dr   Doris Ka Ying   Miu
Department/Unit Medicine and Geriatrics
Institute/Hospital Kwong Wah Hospital

Contact person
Name Dr   Doris Ka Ying   Miu
Department/Unit Medicine and Geriatrics
Institute/Hospital Kwong Wah Hospital
Phone 35175326
Fax 35175244
Internet Mail donnamiu@hotmail.com

Disease/s or Condition/s
Dementia

Intervention/s
Intervention 1
Intervention Name Aerobic exercise training
Type of Intervention Procedure
Duration 3 Months
Other details
Active Control YES

Inclusion and Exclusion Criteria
Gender Non-specific
Age >60
Inclusion and Exclusion Criteria 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 Type Interventional
Purpose Educational / Counselling / Training
Allocation Randomized controlled trial
Masking Single blind
Control Active
Assignment Parallel
Endpoint Efficacy

Primary Outcome/s
Outcome name Physical function measurement using SF-12
Timepoint every 3 months for 1 year
Outcome name Affective function measurement by Cornell depression score
Timepoint every 3 months for 1 year
Outcome name Cognitive function by MMSE and ADAS-cog
Timepoint every 3 months for 1 year

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

Date of First Enrollment 2006-01-01
(yyyy-mm-dd)

Target Sample Size 64

Recruitment Status Recruiting

Funding Source/s
Name
Address or contact information

Primary Sponsor
Name Hospital Authority
Address or contact information Miu Ka Ying Doris, Department of Medicine and Geriatrics, KWH

Secondary Sponsor
Name
Address or contact information

Research Ethics Board/Committee Approval YES

Co-Investigator/s
Name Dr Ying Fai Mak
Department Medicine
Organization Queen Elizabeth Hospital


Study Site/s
Local site/s Department Organization
1 Medicine and Geriatrics Kwong Wah Hospital

Clinical Specialty Internal Medicine

Proposed Date of Last Follow-up 2007-10-01
(yyyy-mm-dd)

Registration Date 2005-12-30
(yyyy-mm-dd)

Submission Date 2005-12-30
(yyyy-mm-dd)

Record Status Confirmed by the Principal Investigator. June 2006