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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05085535
Other study ID # TM-ET
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 8, 2024
Est. completion date December 30, 2024

Study information

Verified date March 2024
Source Omphis Foundation
Contact Juan Vicente López Díaz, Doctor
Phone +34609724888
Email juanlopez@pold.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research project is part of the process of generating scientific evidence, on whether the clinical results obtained, in the treatment of the consequences of aging on mobility, pain and disability, are better if therapeutic exercise programs are added sessions of manual therapy and training in pain awareness, or on the contrary, do not significantly modify the effect of exercise programs.


Description:

General objective: Find out if adding Manual Therapy (MT) sessions to therapeutic exercise programs increases the efficacy of clinical results for the treatment of ailments derived from aging in older adults (65


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria: - People of both sexes. - Between 65 and 85 years of age. - No acute pathologies at the time of selection. - Who present symptoms of muscle-joint degenerative mechanical aging with an intensity score greater than 4 on a scale of 0-10. Exclusion Criteria: - Patients with a recent traumatic history. - Presence of an acute-type radiation component of neurological origin to upper or lower limbs. - With neurological alterations both central and peripheral. - Who are taking opioid-based analgesic medication, gabapentin, etc. - Patients with severe malformations. - Who are following any other type of treatment, be it manual or physical agents or alternative or complementary therapies. - Those who have been treated with infiltrations or the like in a period of less than a year before starting the study. - Patients with a serious psychiatric history such as schizophrenia or psychopathies. - Patients with cognitive impairment. - Patients with vestibular problems that cannot tolerate oscillatory movements. - Those who are contraindicated due to their general metabolic or cardiopulmonary state to carry out moderate physical exercise.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Manual Therapy
Exercises for body mobility and muscle toning, Sophrology, musculoskeletal oscillatory manual therapy
Exercise
Exercises for body mobility and muscle toning, Sophrology

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
JUAN V. LOPEZ DIAZ Omphis Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary Change of subjective assessment of pain intensity using a VAS TEST (Visual Analog Score for pain) (Minimum = 0 better and maximum = 10 worse) beginning and through study completion, an average of 12 weeks
Primary Change of the qualitative aspects of pain using the McGill pain questionnary beginning and through study completion, an average of 12 weeks
Primary Change of of disability and health status using the SF36 test (36-item short form health survey) beginning and through study completion, an average of 12 weeks
Secondary Change of risk of falls Tinetti test. (test for balance and gait) (Minimum = 0 worse and maximum = 28 better) beginning and through study completion, an average of 12 weeks
Secondary Change of Physical activity in older adults PASE test (Physical Activity Scale for the Elderly) beginning and through study completion, an average of 12 weeks
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