DementiaNCT00497822
A Randomized Controlled Trial on the Effect of Exercise on Physical, Cognitive and Affective Function in Dementia Subjects
A study testing Aerobic exercise training in people with Dementia, run by Hospital Authority, Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Aerobic exercise training
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- MMSE<10
- live in old age home
- poor mobility, unable to attend exercise training
- no carer to bring patient to attend hospital training
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Kwong Wah Hospital
Hong Kong
Ying Fai Mak, Dr
About this study
Official 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
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.
- Conditions
- Dementia
- Being tested
- Aerobic exercise training
- Keywords
- Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function measurement using SF-12
Measured: every 3 months for 1 year
Affective function measurement by Cornell depression score
Measured: every 3 months for 1 year
Cognitive function by MMSE and ADAS-cog
Measured: every 3 months for 1 year
Secondary outcomes (3)
6 minutes walk, functional reach, Berg balance scale
Measured: every 3 months for 1 year
Carer stress scale
Measured: every 3 months for 1 year
No. of fall/restricted activity days/time spend in exercise or walking
Measured: every 3 months for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startJan 2006
- Study completionOct 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Doris KY Miu, Dr, Principal investigator, Department of Medicine and Geriatrics, Kwong Wah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497822
- Sponsor's protocol ID
- KW/EX05-090
- Other IDs
- HARECCTR0500054
- Status last verified
- Jul 2010
- First submitted
- 6 Jul 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00497822
- Acronym / sponsor ID
- KW/EX05-090
- Conditions
- Dementia
- Keywords
- Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Jan 2006
- Study completion
- Oct 2007 (estimated)
- First posted
- 9 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- MMSE<10
- live in old age home
- poor mobility, unable to attend exercise training
- no carer to bring patient to attend hospital training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise training | Procedure or surgery | – |
Primary outcome
Physical function measurement using SF-12
Time frame: every 3 months for 1 year
Affective function measurement by Cornell depression score
Time frame: every 3 months for 1 year
Cognitive function by MMSE and ADAS-cog
Time frame: every 3 months for 1 year
3 secondary outcomes
6 minutes walk, functional reach, Berg balance scale
Time frame: every 3 months for 1 year
Carer stress scale
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris KY Miu, Dr principal investigator
Department of Medicine and Geriatrics, Kwong Wah Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training in people with Dementia, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doris KY Miu, Dr ((852) 3517 5326, donnamiu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function measurement using SF-12 (time frame: every 3 months for 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.