Clinical trial NCT05703152: Effect of a Combined Exercise Program on Neuropathic Pain and Perceived Quality of Life in Type 2 Diabetes
Official title: Effect of a Combined Therapeutic Exercise Program on Neuropathic Pain and Perceived Quality of Life in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Neuropathic Pain
Neuropathy, Diabetic
Keywords: Diabetes Mellitus type 2
Neuropathic pain
combined exercise
Lead sponsor: Universidad Autónoma de Yucatán
Sponsor class: OTHER
Collaborators: name: Universidad Autónoma de Yucatán
First posted: 2023-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, longitudinal, quasi-experimental study of repeated measures (pretest-posttest)
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in neuropathic pain on Douleur Neuropathique-4 (DN4) at 8 weeks
timeFrame: Baseline and week 8
measure: Change from baseline in pain intensity on Visual Analogue Scale (VAS) at 8 weeks
timeFrame: Baseline and week 8
measure: Change from baseline in quality of life on the short form-36 questionnaire (SF-36) at 8 weeks
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Socio-demographic data
timeFrame: Before intervention
measure: Clinical data
timeFrame: Before intervention
measure: Weight measurement
timeFrame: Before intervention
measure: Height measurement
timeFrame: Before intervention
measure: Body Mass Index (BMI) measurement
timeFrame: Before intervention
Other outcomes:
Locations:
city: Mérida
country: Mexico
facility: Unidad Universitaria de Inserción Social San José Tecoh
state: Yucatán
Study officials:
affiliation: Facultad de Medicina
name: Maria Gabriela Aké Palomo
role: PRINCIPAL_INVESTIGATOR
affiliation: Falcultad de Medicina
name: Damaris Francis Estrella Castillo, PhD
role: STUDY_DIRECTOR
affiliation: Facultad de Enfermeria
name: Gloria de los Ángeles Uicab Pool, PhD
role: STUDY_DIRECTOR
affiliation: Facultad de Medicina
name: Hector Armado Rubio Zapata
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.