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

Maria Gabriela Aké Palomo12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2 Neuropathic Pain Neuropathy, Diabetic

Interventions

Combined ExerciseOTHER

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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Unidad Universitaria de Inserción Social San José Tecoh

Mérida, Yucatán, Mexico

Outcomes

Primary Outcomes

Change from baseline in neuropathic pain on Douleur Neuropathique-4 (DN4) at 8 weeks

The DN4 questionnaire will be used to evaluate neuropathic pain and its characteristics. DN4 for neuropathic pain consists of interview questions and physical tests. It has 10 items grouped into four questions: seven items relating to the pain description (burning, painful cold, electric shocks) and to its associated abnormal sensations (tingling, pins and needles, numbness, itching), and the other three items relating to a brief bedside neurological examination in the painful area (touch hypoaesthesia, pinprick hypoaesthesia and tactile dynamic allodynia). For scoring, 1 is given to each positive and 0 to each negative item (total score range 0-10). The cut-off value for diagnosis of neuropathic pain is a total score of 4.

Time frame: Baseline and week 8

Change from baseline in pain intensity on Visual Analogue Scale (VAS) at 8 weeks

Pain severity will be assessed using VAS. Each patient will be asked to choose in a perpendicular line on the VAS at the point that signifies the pain severity. The score is ranged 0-10, 0 suggests no pain and 10 suggest severe pain.

Time frame: Baseline and week 8

Change from baseline in quality of life on the short form-36 questionnaire (SF-36) at 8 weeks

The 36-item questionnaire consists of eight domains (general health, mental health, role emotion, role physical, body pain, social function, physical function and vitality), which can be further aggregated into a physical component score (PCS) and mental component score (MCS). Total score ranges from 0 to 100, 0 indicates the poor quality of life and 100 indicates the best quality of life.

Time frame: Baseline and week 8

Secondary Outcomes

Socio-demographic data

An identification form will be filled out at the beginning of the study that will include socio-demographic information: sex (woman/man), age (years), marital status (single/married/widowed/divorced), educational stage (Primary education/High School/University/Master) and occupation (yes/no). All data will be presented in frequency and percentage.

Data from ClinicalTrials.gov

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