The Effects of Different Exercises on Tissue Mechanics, Strength and Neuropathy Symptoms in Type 2 Diabetes Patients

NCT05422235 | Completed

• 1 other identifier: ETK00-2021-0195
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the effects of aerobic exercise and foot exercises in addition to aerobic exercise on lower extremity distal tissue mechanics, muscle strength and neuropathy symptoms in type 2 diabetics with peripheral neuropathy. Subjects will be divided into three groups through randomization.Subjects in the 1st group will be included in the control group and will continue their routine medical treatment for 12 weeks. Subjects in the 2nd group, in addition to their medical treatment, only aerobic exercise training,subjects in the 3rd group will be given aerobic exercise training and exercises for the foot and ankle in addition to their medical treatment. After 12 weeks of training, subjects will be followed for another 12 weeks. subjects will be evaluated before treatment, at 12 and 24 weeks.

Conditions

Diabetic Foot; Peripheral Neuropathy with Type 2 Diabetes

Keywords

Diabetic foot; Peripheral Neuropathy with Type 2 Diabetes; Aerobic exercise; stiffness

Outcome Measures

Primary Outcomes (1)

• Changes passive ankle stiffness compared with baseline and last measurement and Follow-up

  Passive ankle stiffness will be measured before treatment, after treatment, and at follow-up.passive ankle stiffness will be evaluated with an isokinetic dynamometer.

  Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 20 minutes.

Secondary Outcomes (8)

• Changes Plantar Flexion and Dorsiflexion muscle strength compared with baseline and last measurement and Follow-up

  Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 20 minutes.

• Changes Douleur Neuropathique 4 (DN4) compared with baseline and last measurement and Follow-up

  Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 10 minutes.

• Changes plantar pressure compared with baseline and last measurement and Follow-up

  Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 10 minutes.

• Changes foot function compared with baseline and last measurement and Follow-up

  Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 5 minutes.

• Changes quality of life compared with baseline and last measurement and Follow-up

  Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 5 minutes.

Study Arms (3)

Control Group

OTHER

Subjects in this group will be asked to continue their routine medical treatment for 24 weeks.

Other: Routine Medical Treatment

Aerobic Exercise

EXPERIMENTAL

In order to determine the exercise capacity of subjects, submaximal exercise test will be performed.Aerobic training will be done 3 days a week for 12 weeks. Subjects will be followed for 24 weeks.

Other: Routine Medical Treatment; Other: Aerobic Exercise

Aerobic Exercise+ Foot-Related Exercises

EXPERIMENTAL

In addition to walking training specific to the subject in the 2nd group, special exercises will be given to the feet and ankles. These exercises will be aimed at stretching, strengthening, increasing sensory input. Treatment program will be done 3 days a week for 12 weeks. Participants will be followed for 24 weeks.

Other: Routine Medical Treatment; Other: Aerobic Exercise+ Foot-Related Exercise

Interventions

Routine Medical Treatment OTHER

Subjects will continue their routine medical treatment.

Aerobic Exercise; Aerobic Exercise+ Foot-Related Exercises; Control Group

Aerobic Exercise OTHER

Symptom-limited peak heart rates of subjects will be determined using the modified Bruce Protocol. For aerobic training, subject will be carried out on the treadmill according to the results of exercise tests. Initially, 40-60% of the peak heart rate will be trained and progression will be made in subject training programs every 2 weeks. Training will consist of warm-up, main exercise and cool-down periods. Aerobic training will be done 3 days a week for 12 weeks. Subjects will be followed for 24 weeks. The room temperature will be fixed at 25°C in order to keep the impact of environmental factors at a minimum. In addition, individuals will be asked to come with appropriate shoes and clothes for the training.

Aerobic Exercise

Aerobic Exercise+ Foot-Related Exercise OTHER

In addition to walking training specific to the subject in the aerobic exercise group, special exercises will be given to the feet and ankles. These exercises will be aimed at stretching, strengthening, increasing sensory input. Treatment program will be done 3 days a week for 12 weeks. Subjects will be followed for 24 weeks.

Aerobic Exercise+ Foot-Related Exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with Type 2 DM
• Being able to walk independently
• Getting at least 23 points from the mini mental test
• Patients with peripheral neuropathy according to ADA criteria

You may not qualify if:

• Presence of active ulcer
• Amputation history
• History of lower extremity surgery
• Participating in a regular exercise program in the last three months
• Having a Charcot deformity
• Presence of major vascular complications

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Mersin, Famagusta, 99450, Turkey (Türkiye)

Location

Related Publications (24)

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MeSH Terms

Conditions

Diabetic Foot

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Cansu KOLTAK, MSc

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

• Yasin YURT, PhD

  Eastern Mediterranean University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The physiotherapist who evaluated the individuals participating in the study and the physiotherapist who took the treatment will not be the same. in addition, an independent statistician will do the analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: March 12, 2022
• Primary Completion: February 28, 2025
• Study Completion: March 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2022-02

Locations

TU (1)