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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05703152
• Other study ID #: Folio No. 06-2022
• Status: Completed
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: November 2023
• Source: Universidad Autónoma de Yucatán
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Neuropathies
• Neuralgia
• Neuropathic Pain
• Neuropathy, Diabetic

Intervention

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.

Locations

Country	Name	City	State
Mexico	Unidad Universitaria de Inserción Social San José Tecoh	Mérida	Yucatán

Sponsors (2)

Lead Sponsor	Collaborator
Maria Gabriela Aké Palomo	Universidad Autónoma de Yucatán

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

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. — View 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 — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and week 8
Primary	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.	Baseline and week 8
Primary	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.	Baseline and week 8
Secondary	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.	Before intervention
Secondary	Clinical data	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
Secondary	Weight measurement	Body weight will be measured in kilograms (kg) using the body weight scale "Omron HBF-514C".	Before intervention
Secondary	Height measurement	Height will be measured in meters (m) using a stadiometer.	Before intervention
Secondary	Body Mass Index (BMI) measurement	BMI will be calculated by dividing the weight in kilograms by the height in metres squared (kg/m^2).	Before intervention