Study of Manual Therapy Plus Therapeutic Exercise in Geriatrics

NCT ID: NCT05085535

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-08
• Study Completion Date: 2024-12-30

Brief 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.

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-).

Conditions

Pain; Disability Physical; Aging Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Exercise

to which the treatment of therapeutic exercise and pain education will be applied,

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

Exercises for body mobility and muscle toning, Sophrology

Manual Therapy

to which the same treatment as the control group will be applied, adding manual therapy sessions based on musculoskeletal rhythmic mobilizations.

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: OTHER

Exercises for body mobility and muscle toning, Sophrology, musculoskeletal oscillatory manual therapy

Interventions

Manual Therapy

Exercises for body mobility and muscle toning, Sophrology, musculoskeletal oscillatory manual therapy

Intervention Type: OTHER

Exercise

Exercises for body mobility and muscle toning, Sophrology

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Omphis Foundation

OTHER

Sponsor Role: collaborator

Juan Vicente, López Díaz

OTHER

Sponsor Role: lead

Responsible Party

Juan Vicente, López Díaz

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Juan Vicente López Díaz

Role: PRINCIPAL_INVESTIGATOR

Fundación Omphis

Other Identifiers

TM-ET

Identifier Type: -

Identifier Source: org_study_id