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

NCT05703152 | Completed DMC

• 1 other identifier: Folio No. 06-2022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Neuropathic Pain; Neuropathy, Diabetic

Keywords

Diabetes Mellitus type 2; Neuropathic pain; combined exercise

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Socio-demographic data

  Before intervention

• Clinical data

  Before intervention

• Weight measurement

  Before intervention

• Height measurement

  Before intervention

• Body Mass Index (BMI) measurement

  Before intervention

Study Arms (1)

Combined Exercise

EXPERIMENTAL

Therapeutic exercise program

Other: Combined Exercise

Interventions

Combined Exercise 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.

Combined Exercise

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with several limit function
• Patients with foot ulcer or amputation
• Patients who are involved in a exercise program already

Sponsors & Collaborators

• Maria Gabriela Aké Palomo: lead
• Universidad Autónoma de Yucatán: collaborator

Study Sites (1)

Unidad Universitaria de Inserción Social San José Tecoh

Mérida, Yucatán, 97299, Mexico

Location

Related Publications (6)

• 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.

  PMID: 27999003 BACKGROUND

• 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.

  PMID: 30586071 BACKGROUND

• 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.

  PMID: 18053212 BACKGROUND

• 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.

  PMID: 32187271 BACKGROUND

• 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.

  PMID: 35029593 BACKGROUND

• 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.

  PMID: 30045740 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Neuralgia; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Complications

Study Officials

• Maria Gabriela Aké Palomo

  Facultad de Medicina

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Maria Gabriela Aké Palomo

Model Details: A prospective, longitudinal, quasi-experimental study of repeated measures (pretest-posttest)

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 27, 2023
• Study Start: October 31, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)