Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-28 @ 7:18 AM
Study NCT ID:
NCT05085535
Status:
WITHDRAWN
Last Update Posted:
2025-06-29
First Post:
2021-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Manual Therapy Plus Therapeutic Exercise in Geriatrics
Sponsor:
Juan Vicente, López Díaz
Organization:
Study Overview
Official Title:
Study of the Effect of Adding Manual Therapy to Therapeutic Exercise Programs in Older Adults With Limited Mobility and Pain Secondary to Aging.
Status:
WITHDRAWN
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not enough participants were recruited for a quality study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: