NCT05494879

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

August 17, 2022

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2023

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

13 days

First QC Date

July 29, 2022

Last Update Submit

August 9, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change of the Senior Fitness Test

    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.

    baseline, 1-month follow-up

  • Change of the gait parameters

    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).

    baseline, 1-month follow-up

  • Change of the quality of life

    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

    baseline, 1-month follow-up

  • Change of the mental health

    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

    baseline, 1-month follow-up

Study Arms (1)

microkinesitherapy treatment

EXPERIMENTAL

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.

Behavioral: microkinesitherapy treatment

Interventions

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".

microkinesitherapy treatment

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent to participate in the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Education and Physiotherapy, Opole University of Technology

Opole, 45-758, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 10, 2022

Study Start

August 17, 2022

Primary Completion

August 30, 2022

Study Completion

July 18, 2023

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

The data presented in this study are available upon request from the corresponding author.

Shared Documents
STUDY PROTOCOL
Time Frame
6-months

Locations