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Effect of a Combined Exercise Program on Neuropathic Pain and Perceived Quality of Life in Type 2 Diabetes

NCT ID: NCT05703152

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2023-07-31

Brief Summary

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Therapeutic exercise is one of the therapies used as a treatment for diabetic neuropathy, which is a complication of diabetes. In order to reduce pain and improve the perception of quality of life, a combined therapeutic exercise program will be implemented as an adjuvant and non-pharmacological treatment for diabetic neuropathy.

Detailed Description

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This is a prospective, longitudinal, quasi-experimental study of repeated measures (pretest-posttest), has been approved by the research and ethics committee of the Faculty of Medicine of the Autonomous University of Yucatan, issuing a report on October 26, 2022. An identification form will be filled out that will include socio-demographic and clinical data: presence of type II diabetes, presence of neuropathy, sex, age, marital status, schooling, occupation, BMI, time of diagnosis, HbA1C, insulin use, medical treatment and a neurological examination of the extremities. The DN4 questionnaire will be used to evaluate neuropathic pain and its characteristics, the VAS will be used to evaluate the degree of intensity or severity of pain, and the SF-36 questionnaire will be used to evaluate perception before and after the combined exercise program. During the intervention stage, a therapeutic exercise program will be applied that will include two modalities: aerobic and resistance exercise in the facilities of the Unidad Universitaria de Inserción social de San José Tecoh. The duration will be 8 weeks with a frequency of 3 sessions per week, with a duration per session of 60 minutes each, to achieve the minimum total time suggested by the guidelines of 150 minutes per week. These exercises will be prescribed in three phases to increase times, series, repetitions and resistances in a progressive manner according to the Borg scale. For the analysis of the variables, the parametric Student's t-test for related samples or the nonparametric Wilcoxon test with significance at 95% reliability will be used. The implementation of the study can demonstrate significant improvements in the symptomatology of diabetic neuropathy, directly impacting on the perception of the quality of life of patients with type II diabetes.

Conditions

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Diabetes Mellitus, Type 2 Neuropathic Pain Neuropathy, Diabetic

Keywords

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Diabetes Mellitus type 2 Neuropathic pain combined exercise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospective, longitudinal, quasi-experimental study of repeated measures (pretest-posttest)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combined Exercise

Therapeutic exercise program

Group Type EXPERIMENTAL

Combined Exercise

Intervention Type OTHER

Therapeutic exercise program will be applied that will include two modalities: aerobic and resistance exercise. The duration will be 8 weeks with a frequency of 3 sessions per week, with a duration per session of 60 minutes.

Interventions

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Combined Exercise

Therapeutic exercise program will be applied that will include two modalities: aerobic and resistance exercise. The duration will be 8 weeks with a frequency of 3 sessions per week, with a duration per session of 60 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with diabetes type 2
* Patients with neuropathy
* Patients with medical treatment

Exclusion Criteria

* Patients with several limit function
* Patients with foot ulcer or amputation
* Patients who are involved in a exercise program already
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autónoma de Yucatán

OTHER

Sponsor Role collaborator

Maria Gabriela Aké Palomo

OTHER

Sponsor Role lead

Responsible Party

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Maria Gabriela Aké Palomo

Maria Gabriela Aké Palomo

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Maria Gabriela Aké Palomo

Role: PRINCIPAL_INVESTIGATOR

Facultad de Medicina

Damaris Francis Estrella Castillo, PhD

Role: STUDY_DIRECTOR

Falcultad de Medicina

Gloria de los Ángeles Uicab Pool, PhD

Role: STUDY_DIRECTOR

Facultad de Enfermeria

Hector Armado Rubio Zapata

Role: STUDY_DIRECTOR

Facultad de Medicina

Locations

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Unidad Universitaria de Inserción Social San José Tecoh

Mérida, Yucatán, Mexico

Site Status

Countries

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Mexico

References

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Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.

Reference Type BACKGROUND
PMID: 27999003 (View on PubMed)

Scholz J, Finnerup NB, Attal N, Aziz Q, Baron R, Bennett MI, Benoliel R, Cohen M, Cruccu G, Davis KD, Evers S, First M, Giamberardino MA, Hansson P, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Nurmikko T, Perrot S, Raja SN, Rice ASC, Rowbotham MC, Schug S, Simpson DM, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ, Barke A, Rief W, Treede RD; Classification Committee of the Neuropathic Pain Special Interest Group (NeuPSIG). The IASP classification of chronic pain for ICD-11: chronic neuropathic pain. Pain. 2019 Jan;160(1):53-59. doi: 10.1097/j.pain.0000000000001365.

Reference Type BACKGROUND
PMID: 30586071 (View on PubMed)

Perez C, Galvez R, Huelbes S, Insausti J, Bouhassira D, Diaz S, Rejas J. Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component. Health Qual Life Outcomes. 2007 Dec 4;5:66. doi: 10.1186/1477-7525-5-66.

Reference Type BACKGROUND
PMID: 18053212 (View on PubMed)

Pereira EV, Tonin FS, Carneiro J, Pontarolo R, Wiens A. Evaluation of the application of the Diabetes Quality of Life Questionnaire in patients with diabetes mellitus. Arch Endocrinol Metab. 2020 Feb;64(1):59-65. doi: 10.20945/2359-3997000000196. Epub 2020 Mar 13.

Reference Type BACKGROUND
PMID: 32187271 (View on PubMed)

Kanaley JA, Colberg SR, Corcoran MH, Malin SK, Rodriguez NR, Crespo CJ, Kirwan JP, Zierath JR. Exercise/Physical Activity in Individuals with Type 2 Diabetes: A Consensus Statement from the American College of Sports Medicine. Med Sci Sports Exerc. 2022 Feb 1;54(2):353-368. doi: 10.1249/MSS.0000000000002800.

Reference Type BACKGROUND
PMID: 35029593 (View on PubMed)

Pan B, Ge L, Xun YQ, Chen YJ, Gao CY, Han X, Zuo LQ, Shan HQ, Yang KH, Ding GW, Tian JH. Exercise training modalities in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis. Int J Behav Nutr Phys Act. 2018 Jul 25;15(1):72. doi: 10.1186/s12966-018-0703-3.

Reference Type RESULT
PMID: 30045740 (View on PubMed)

Other Identifiers

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Folio No. 06-2022

Identifier Type: -

Identifier Source: org_study_id