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Completed

NCT Number: NCT05703152

Effect of a Combined Exercise Program on Neuropathic Pain and Perceived Quality of Life in 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Neuropathy, Diabetic Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidad Universitaria de Inserción Social San José Tecoh

Mérida, Yucatán, 97299, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Weight measurement

    Time frame: Before intervention

    Body weight will be measured in kilograms (kg) using the body weight scale "Omron HBF-514C".

  4. Height measurement

    Time frame: Before intervention

    Height will be measured in meters (m) using a stadiometer.

  5. 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).

Sponsors and collaborators

Lead sponsor

Maria Gabriela Aké Palomo

Other

Collaborators

  • Universidad Autónoma de Yucatán

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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