Mild Cognitive ImpairmentNCT03507192
Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.
A study testing Muscle relaxation using full body massage machine in people with Mild Cognitive Impairment and Alzheimer Dementia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Muscle relaxation has been reported to be effective in alleviating anxiety and agitation symptoms in patients with dementia, but no studies have examined the effects of muscle relaxation therapy on cognitive function changes. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Dementia
- What is being tested?
- Muscle relaxation using full body massage machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2017to 31 Dec 2019
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria (1) Subjects aged 50 to 85 years who understand and agree to the purpose of the study (2) mild cognitive impairment or early stage of Alzheimer dementia (3) CDR of 0.5~1
- Exclusion Criteria (1) severe cerebral white matter hyperintensities on brain MRI : defined as deep white matter ≥ 2.5 cm, caps or band ≥ 1.0 cm (2) cancer or severe medical illness (3) fear of magnetic resonance imaging (MRI) examination (claustrophobia) (4) MRI contrast agent side effects (4) pacemaker or a metal material which can not be detached (prosthetics, braces, etc.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 06351
Sang Won Seo, MD. PhD.
Young Hee Jung, MD, +82-10-6755-5462, neophilia1618@gmail.com
About this study
Muscle relaxation has been reported to be effective in alleviating anxiety and agitation symptoms in patients with dementia, but no studies have examined the effects of muscle relaxation therapy on cognitive function changes.
Therefore, the purpose of this study is to compare and validate the improvement of cognitive function in patients with mild cognitive impairment and early alzheimer's dementia aged 50 to 85 years after performing muscle relaxation machine massage regularly.
Read the detailed description
The prevalence of dementia is approximately 5-10% in the elderly who are over 65 years of age. In Korea, the prevalence of dementia among elderly people aged 65 and over was 9.18% in 2012, and the number of patients with dementia was estimated to be 540,755 (155,955 for male, 384,800 for female). The number of patients with dementia will be doubled every 20 years until 2050, which is estimated to be 840,000 in 2020, about 1.27 million in 2030, and 2.71 million in 2050. Alzheimer's disease is the most common cause of dementia, accounting for 55-70% of all dementia. Major risk factors include age, genetic factors, apolipoprotein E gene, female and brain trauma, but stress is also associated with increased risk of Alzheimer's disease.
Stress can be present anywhere in our daily lives, and stress can energize life, but if people are exposed to stress for a long time, they may develop physical symptoms. Severe and long-term stress can cause or exacerbate diseases such as angina, stroke, hypertension, diabetes, tension headache, back pain, irritable bowel syndrome, asthma and arthritis. Studies about the relationship between stress and Alzheimer's disease have shown that the corticotrophin releasing factor secreted when exposed to stress can increase brain toxic protein such as beta amyloid plaques that are known to be responsible for dementia.
There are various ways to overcome stress, like meditation, yoga and relaxation training methods that individuals can do at home. Relaxation training methods include relaxation using breathing and progressive muscle relaxation. Progressive muscle relaxation therapy stabilizes anxious psychology by stretching and relaxing several muscles of the body in turn. Muscle relaxation promotes arterial and venous flow, lymphatic flow, reduces edema of muscles and connective tissues, and improves organ function to aid homeostasis.
Muscle relaxation has been reported to be effective in alleviating anxiety and agitation symptoms in patients with dementia, but no studies have examined the effects of muscle relaxation therapy on cognitive function changes.
Therefore, the purpose of this study is to compare and validate the improvement of cognitive function in patients with mild cognitive impairment and early alzheimer's dementia aged 50 to 85 years after performing muscle relaxation machine massage regularly.
- Conditions
- Mild Cognitive Impairment, Alzheimer Dementia
- Being tested
- Muscle relaxation using full body massage machine
- Keywords
- MCI, Alzheimer's disease, muscle relaxation
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle relaxation using full body massage machineDevice
Receiving muscle relaxation machine massage every morning and evening for 30 minutes during a year
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | 30 subjects In arm 1, no intervention is performed. |
| Arm 2 | Active comparator | 30 patients In arm 2 , active comparators, Muscle relaxation using full body massage machine is performed every morning and evening for 30 minutes. Receives: Device: Muscle relaxation using full body massage machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortical thickiness in 3D MRI
changes of cerebral cortical thickness in 3D MRI
Measured: One year after receiving muscle relaxation massage everyday.
Secondary outcomes (1)
functional connectivity in functional MRI
functional connectivity of default mode network in and resting state fMRI
Measured: One year after receiving muscle relaxation massage everyday.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start25 Sep 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang Won Seo, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507192
- Sponsor's protocol ID
- 2017-05-135
- Status last verified
- Apr 2018
- First submitted
- 15 Apr 2018
- Last updated
- 14 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim YJ, Kim HR, Jung YH, Park YH, Seo SW. Effects of Electrical Automatic Massage on Cognition and Sleep Quality in Alzheimer's Disease Spectrum Patients: A Randomized Controlled Trial. Yonsei Med J. 2021 Aug;62(8):717-725. doi: 10.3349/ymj.2021.62.8.717.
PubMed 34296549
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.
- ClinicalTrials.gov ID
- NCT03507192
- Acronym / sponsor ID
- 2017-05-135
- Conditions
- Mild Cognitive Impairment, Alzheimer Dementia
- Keywords
- MCI, Alzheimer's disease, muscle relaxation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 24 Apr 2018 (actual)
- 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.
Muscle relaxation has been reported to be effective in alleviating anxiety and agitation symptoms in patients with dementia, but no studies have examined the effects of muscle relaxation therapy on cognitive function changes.
Therefore, the purpose of this study is to compare and validate the improvement of cognitive function in patients with mild cognitive impairment and early alzheimer's dementia aged 50 to 85 years after performing muscle relaxation machine massage regularly.
Detailed description
The prevalence of dementia is approximately 5-10% in the elderly who are over 65 years of age. In Korea, the prevalence of dementia among elderly people aged 65 and over was 9.18% in 2012, and the number of patients with dementia was estimated to be 540,755 (155,955 for male, 384,800 for female). The number of patients with dementia will be doubled every 20 years until 2050, which is estimated to be 840,000 in 2020, about 1.27 million in 2030, and 2.71 million in 2050. Alzheimer's disease is the most common cause of dementia, accounting for 55-70% of all dementia. Major risk factors include age, genetic factors, apolipoprotein E gene, female and brain trauma, but stress is also associated with increased risk of Alzheimer's disease.
Stress can be present anywhere in our daily lives, and stress can energize life, but if people are exposed to stress for a long time, they may develop physical symptoms. Severe and long-term stress can cause or exacerbate diseases such as angina, stroke, hypertension, diabetes, tension headache, back pain, irritable bowel syndrome, asthma and arthritis. Studies about the relationship between stress and Alzheimer's disease have shown that the corticotrophin releasing factor secreted when exposed to stress can increase brain toxic protein such as beta amyloid plaques that are known to be responsible for dementia.
There are various ways to overcome stress, like meditation, yoga and relaxation training methods that individuals can do at home. Relaxation training methods include relaxation using breathing and progressive muscle relaxation. Progressive muscle relaxation therapy stabilizes anxious psychology by stretching and relaxing several muscles of the body in turn. Muscle relaxation promotes arterial and venous flow, lymphatic flow, reduces edema of muscles and connective tissues, and improves organ function to aid homeostasis.
Muscle relaxation has been reported to be effective in alleviating anxiety and agitation symptoms in patients with dementia, but no studies have examined the effects of muscle relaxation therapy on cognitive function changes.
Therefore, the purpose of this study is to compare and validate the improvement of cognitive function in patients with mild cognitive impairment and early alzheimer's dementia aged 50 to 85 years after performing muscle relaxation machine massage regularly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –30 subjects In arm 1, no intervention is performed. |
| Arm 2 | Active comparator | Device: Muscle relaxation using full body massage machine30 patients In arm 2 , active comparators, Muscle relaxation using full body massage machine is performed every morning and evening for 30 minutes. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Muscle relaxation using full body massage machineReceiving muscle relaxation machine massage every morning and evening for 30 minutes during a year | Device | Arm 2 |
Primary outcome
cortical thickiness in 3D MRI
Time frame: One year after receiving muscle relaxation massage everyday.
changes of cerebral cortical thickness in 3D MRI
1 secondary outcome
functional connectivity in functional MRI
Time frame: One year after receiving muscle relaxation massage everyday.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Derived from this study: PubMed 34296549Kim YJ, Kim HR, Jung YH, Park YH, Seo SW. Effects of Electrical Automatic Massage on Cognition and Sleep Quality in Alzheimer's Disease Spectrum Patients: A Randomized Controlled Trial. Yonsei Med J. 2021 Aug;62(8):717-725. doi: 10.3349/ymj.2021.62.8.717.
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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.
Sang Won Seo, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle relaxation using full body massage machine in people with Mild Cognitive Impairment and Alzheimer Dementia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Mar 2019. 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 South Korea. 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 Sang Won Seo, MD, PhD (+82-2-3410-1233, sangwonseo@empal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortical thickiness in 3D MRI (time frame: One year after receiving muscle relaxation massage everyday.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03507192, which also lists 1 linked publication.
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 14 Mar 2019.