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

November 28, 2023 updated by: Maria Gabriela Aké Palomo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Yucatán
      • Mérida, Yucatán, Mexico, 97299
        • Unidad Universitaria de Inserción Social San José Tecoh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined Exercise
Therapeutic exercise program
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in neuropathic pain on Douleur Neuropathique-4 (DN4) at 8 weeks
Time Frame: Baseline and week 8
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.
Baseline and week 8
Change from baseline in pain intensity on Visual Analogue Scale (VAS) at 8 weeks
Time Frame: Baseline and week 8
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.
Baseline and week 8
Change from baseline in quality of life on the short form-36 questionnaire (SF-36) at 8 weeks
Time Frame: Baseline and week 8
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.
Baseline and week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-demographic data
Time Frame: Before intervention
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.
Before intervention
Clinical data
Time Frame: Before intervention

An identification form will be filled out at the beginning of the study that will include clinical information: presence of type II diabetes, presence of neuropathy, time of diagnosis (years), Glycemic status (A1C percentage), insulin use (yes/no) and medical treatment. All data will be presented in frequency and percentage.

For the neurological examination of the extremities, three instruments will be used: the 10g or Semmes-Weinstein monofilament, 128 hertz tuning fork and Taylor reflex hammer.
Before intervention
Weight measurement
Time Frame: Before intervention
Body weight will be measured in kilograms (kg) using the body weight scale "Omron HBF-514C".
Before intervention
Height measurement
Time Frame: Before intervention
Height will be measured in meters (m) using a stadiometer.
Before intervention
Body Mass Index (BMI) measurement
Time Frame: Before intervention
BMI will be calculated by dividing the weight in kilograms by the height in metres squared (kg/m^2).
Before intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Gabriela Aké Palomo

Collaborators

Universidad Autónoma de Yucatán

Investigators

  • Principal Investigator: Maria Gabriela Aké Palomo, Facultad de Medicina
  • Study Director: Damaris Francis Estrella Castillo, PhD, Falcultad de Medicina
  • Study Director: Gloria de los Ángeles Uicab Pool, PhD, Facultad de Enfermeria
  • Study Director: Hector Armado Rubio Zapata, Facultad de Medicina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Folio No. 06-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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