Study of Manual Therapy Plus Therapeutic Exercise in Geriatrics

March 18, 2024 updated by: JUAN V. LOPEZ DIAZ

Study of the Effect of Adding Manual Therapy to Therapeutic Exercise Programs in Older Adults With Limited Mobility and Pain Secondary to Aging.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 <age <85).

Specific objectives:

  1. Assess the effects on pain. (hypothesis: MT improves pain outcomes)
  2. Assess the effects on physical disability. (hypothesis: MT improves results regarding physical disability)
  3. Assess the effects on mental disability. (hypothesis: MT improves results regarding mental disability)
  4. Assess the effects on the prevention of falls (hypothesis: MT improves the results regarding the risk of falls)

Methodology:

Study design: It is a study of the randomized clinical trial type, with triple blind.

Selection of participants:

1. General criteria:

  • The sample will be selected from the patients who volunteer to participate in the study, which will be announced by the media (Radio and / or TV) and meet the inclusion criteria and not the exclusion criteria.
  • Participants will be treated by different therapists, who will be instructed in the treatments to be performed on the participants, to eliminate the therapist's personal factor as a contaminating variable.
  • Participants will be referred to the physiotherapist according to the group assigned by the randomization process, which will be unknown by the patient.

Sample size:

To calculate the sample size, the EPIDAT 4.2 or GRANMO 7.12 computer program will be used, depending on the population and epidemiological data of the Catalunya area, of older adults, with disabilities and mechanical-degenerative pain.

If the calculation is made based on a Student's t test for independent data, accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 25 subjects would be required in each group to detect a minimum difference of 20 percentage points. between two groups, assuming a common standard deviation of 25 points, and a loss to follow-up rate of 0%, following the usual criteria of biostatistics in health sciences (1) and the criteria of minimal differences between groups previously used in similar pilot studies.

In case of loss of subjects in the sample, participants should be replaced by others to maintain proportions. The definitive calculations will be made with more precision after the epidemiological study mentioned above.

Randomization Of all the participants who meet the inclusion criteria and do not have any exclusion criteria, a number will be assigned, after being randomized through a computerized process, to distribute each number to the corresponding group. The patient will not know which group he has been assigned to.

Analytical procedure:

Analysis by computer processing with SPSS 22.0 ® program. Performed by a blinded computer analyst.

Ethical aspects:

During the study, national and international guidelines (code of ethics, Declaration of Helsinki) will be followed, as well as the legal regulations on data confidentiality (Organic Law 3/2018 of December 5 on the Protection of Personal Data and guarantee of digital rights -LOPD-).

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

  • Name: Juan Vicente López Díaz, Doctor
  • Phone Number: +34609724888
  • Email: juanlopez@pold.es

Study Contact Backup

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

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise
to which the treatment of therapeutic exercise and pain education will be applied,
Other: Exercise
Exercises for body mobility and muscle toning, Sophrology
Experimental: Manual Therapy
to which the same treatment as the control group will be applied, adding manual therapy sessions based on musculoskeletal rhythmic mobilizations.
Other: Manual Therapy
Exercises for body mobility and muscle toning, Sophrology, musculoskeletal oscillatory manual therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of subjective assessment of pain intensity
Time Frame: beginning and through study completion, an average of 12 weeks
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
Change of the qualitative aspects of pain
Time Frame: beginning and through study completion, an average of 12 weeks
using the McGill pain questionnary
beginning and through study completion, an average of 12 weeks
Change of of disability and health status
Time Frame: beginning and through study completion, an average of 12 weeks
using the SF36 test (36-item short form health survey)
beginning and through study completion, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of risk of falls
Time Frame: beginning and through study completion, an average of 12 weeks
Tinetti test. (test for balance and gait) (Minimum = 0 worse and maximum = 28 better)
beginning and through study completion, an average of 12 weeks
Change of Physical activity in older adults
Time Frame: beginning and through study completion, an average of 12 weeks
PASE test (Physical Activity Scale for the Elderly)
beginning and through study completion, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JUAN V. LOPEZ DIAZ

Collaborators

Omphis Foundation

Investigators

  • Principal Investigator: Juan Vicente López Díaz, Fundación Omphis

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 (Estimated)

June 8, 2024

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TM-ET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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