- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05494879
Effectiveness of Microkinesitherapy in Seniors
August 9, 2022 updated by: The Opole University of Technology
Evaluation of the Effect of Microkinesitherapy Treatment on Psychosomatic Functions in Community-dwelling Older Adults: A Pilot Study
Many specialists stress that the aging process is individual, its course, severity and occurrence of disease are not the same for all seniors.
The studies indicate that SA should be conceptualized as a process, using developmental trajectories of functioning as component parts, and can take several forms.
The nature of "successful" trajectories varied from a limited decline over time (e.g., cognitive and physical functioning), stability over time (e.g., self-perceived health) to recovery (from social loneliness) and growth (in life satisfaction and emotional support provided).
Therefore, the aim of this study was to investigate the effectiveness of microkinesitherapy treatment in community-dwelling older adults.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
new therapeutic methods are being proposed that can be used in the community to steer the aging process toward "healthy aging."
An example of a holistic approach to the patient can be found in microkinesitherapy.
The focus of microkinesitherapy is to find and restore areas of the body that have lost their vitality and mobility, using gentle touches on various body tissues using specific body maps.
The aim of this study was to investigate the effectiveness of microkinesitherapy treatment in community-dwelling older adults.
It was decided to evaluate the impact of a single therapy session on a range of psycho-somatic indicators.
The hypotheses were as follows: (H1) The microkinesitherapy intervention will improve the physical function assessed using the Senior Fitness Test, (H2) A single microkinesitherapy treatment will not affect gait performance, (H3) A single microkinesitherapy treatment will improve the quality of life of the participants.
Study Type
Interventional
Enrollment (Anticipated)
24
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
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Opole, Poland, 45-758
- Faculty of Physical Education and Physiotherapy, Opole University of Technology
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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
50 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- informed consent to participate in the study
Exclusion Criteria:
- pneumonia, tuberculosis and other respiratory inflammatory disease in all stages and forms
- less than 6 months after a heart attack, state after thoracic and cardiac surgery
- uncontrolled hypertension
- insulin-dependent diabetes
- lung cancer
- cognitive impairment or Mini-Mental State Examination < 24.
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: microkinesitherapy treatment
The study group received a single therapy session of microkinesitherapy.
The entire procedure lasted about 10 minutes.
Microkinesitherapy is based on locating information in the patient's body about previous traumas/traumas that have been experienced physically and emotionally, which the body could not eliminate.
This information is interpreted on the body by sensitive tensions and called "body scars" and does not necessarily remain in the brain.
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The therapeutic session of microkinesitherapy included a seeking of "body scares" both taking into account somatic dysfunctions as well as psychosomatic disorders.
According to the creators of the method, Grosjean and Benini "Everything that happens with us in a toxic level, either physically or emotionally, are stored by the brain which keeps memories and generates links that may harm the function of the cells generating a vast array of symptoms and dysfunctions".
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of the Senior Fitness Test
Time Frame: baseline, 1-month follow-up
|
The Senior Fitness Test (also known as the Fullerton test) was used to assess physical fitness.
Five motor tasks were evaluated, including strength, endurance, flexibility, agility, balance, and motor coordination.
The sixth component of the test: the 6-minute walk test could not be performed due to the patients' low functional status.
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baseline, 1-month follow-up
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Change of the gait parameters
Time Frame: baseline, 1-month follow-up
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Gait cycle analysis was performed with the subject barefoot over a distance of 5 m long and 2 m wide, making 2 passes (10 m) at normal gait speed.
For gait analysis, a wireless inertial sensor system BTS G-WALK (BTS Bioengineering S.p.A., Milan, Italy) was used, placed by means of a semi-elastic belt at the level of the fifth lumbar vertebra (L5) and the first two sacral vertebrae (S1-S2).
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baseline, 1-month follow-up
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Change of the quality of life
Time Frame: baseline, 1-month follow-up
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The WHO's questions stem from multiple statements about quality of life, health and well-being from people with and without disease, and health professionals.
The questionnaire was validated and identifies four major domains: Physical health, Psychological, Social relationships, Environment.
Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale.
The scores are then transformed to a 0-100 or 4-20 scales.
Lower score indicates poorer quality of life
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baseline, 1-month follow-up
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Change of the mental health
Time Frame: baseline, 1-month follow-up
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The GHQ-12 General Health Questionnaire enables the identification of people whose mental state has broken down temporarily or over the long term as a result of difficulties experienced, problems or as a result of mental illness, and those who are at significant risk of mental health disorders.
A version of the GHQ-28 provides an overall score that is an indicator of the patient's mental health, divided into 4 scales: somatic symptoms; anxiety, insomnia; dysfunction and symptoms of depression.
The scoring type used in this study was Likert scoring methods (0-1-2-3).
Higher score indicates greater disorder
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baseline, 1-month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
August 17, 2022
Primary Completion (Anticipated)
August 30, 2022
Study Completion (Anticipated)
July 18, 2023
Study Registration Dates
First Submitted
July 29, 2022
First Submitted That Met QC Criteria
August 9, 2022
First Posted (Actual)
August 10, 2022
Study Record Updates
Last Update Posted (Actual)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Micro_Poznan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The data presented in this study are available upon request from the corresponding author.
IPD Sharing Time Frame
6-months
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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