Clinical trial NCT05422235: The Effects of Different Exercises on Tissue Mechanics, Strength and Neuropathy Symptoms in Type 2 Diabetes Patients
Official title: Comparison of the Effects of Different Exercise Programs on Lower Extremity Distal Tissue Mechanics, Muscle Strength and Neuropathy Symptoms in Type 2 Diabetics with Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Peripheral Neuropathy with Type 2 Diabetes
Keywords: Diabetic foot
Peripheral Neuropathy with Type 2 Diabetes
Aerobic exercise
stiffness
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Detailed description: Diabetes Mellitus (DM) is a chronic metabolic disease that causes fat, protein and carbohydrate metabolism disorders, characterized by hyperglycemia resulting from impaired insulin secretion and insulin activity or both of these factors. The "Sixth Diabetes Atlas" published by IDF (International Diabetes Federation) in 2013 contains important data about the current situation and future of diabetes in the world.Diabetic foot ulcer is shown as the reason for 15-20% of all diabetic individuals to apply to the hospital at least once. Diabetic foot is seen as a public health factor that increases the cost, as it increases the length of stay in the hospital, long-term antibiotic therapy, and overtime of many clinics such as surgery and orthopedics.

Musculoskeletal complications of diabetes are quite common. The severity of macrovascular and microvascular complications increases over time. It poses a risk for the formation of diabetic foot ulcers in diabetic individuals. It has been reported that joint mobility decreases in individuals, especially when the first metatarsophalangeal joint extension falls below 45 degrees, the risk increases. Decrease in distal muscle strength and atrophy occur due to peripheral neuropathy and axonal loss. Loss of strength causes various deformities in the foot. In addition, it has been stated that the plantar flexors are shortened and shortening increases the forefoot pressure in individuals with diabetes. A plantar pressure of more than 70 N/cm2 in the forefoot has also been reported as a risk factor for diabetic foot ulcer.

Physiotherapy approaches for symptoms should be applied in order to eliminate the risks of the disease and increase the quality of life after complications develop and their symptoms appear. Physiotherapy approaches are applied in primary, secondary and tertiary prevention. It is the duty of physiotherapists to educate the patient in primary prevention, to apply the most appropriate exercise training to prevent the development of diabetes-related complications in secondary prevention, and to apply the most appropriate physiotherapy approaches for diabetic foot and its treatment in tertiary prevention.

An important part of diabetic foot preventive methods is preventive exercise training.

Diabetic foot protective exercise aims to minimize the risks that occur or may occur.

Studies have reported that increased forefoot pressure is associated with decreased plantar fascia and Achilles flexibility. It has been stated that aerobic and resistance exercises are effective in glycemic control and HbA1c control, and the risk and symptoms of neuropathy are reduced. Contrary to popular belief, activities that involve standing do not increase the risk of ulceration. When the studies were examined, many studies were found that investigated the effects of aerobic exercise training and exercise training for the foot-ankle on normal joint range of motion, flexibility, muscle strength, walking speed and plantar pressure. However, no study has been found examining the effect of aerobic exercise training and exercise training for the foot and ankle on tissue stiffness.

Hypotheses:

H1: The effects of different exercise programs on lower extremity distal tissue mechanics are different in type 2 diabetics with peripheral neuropathy.

H2: The effects of different exercise programs on lower extremity distal muscle strength are different in type 2 diabetics with peripheral neuropathy.

H3: The effects of different exercise programs on neuropathy symptoms are different in type 2 diabetics with peripheral neuropathy.

H4: The effects of different exercise programs on plantar pressure are different in type 2 diabetics with peripheral neuropathy.

Material and Method:

The study will be conducted on subjects diagnosed with chronic mechanical type 2 diabetes due to distal peripheral neuropathy by specialist physician.Subjects who meet the inclusion and exclusion criteria and sign the informed consent form will be randomly divided into three different groups by random allocation program.

According to the power analysis made using the G-Power program; Assuming that the nonparametric ANOVA test will be used for the comparison between the 3 groups, a two-legged hypothesis will be established and a total of 93 people will be included in the calculation made by taking Cohen d=0.40, α=0.05, β=0.20, 31 in each group. It was decided to take 111 people from the research by predicting a 20% loss.

Subjects will be divided into three groups through randomization. Randomization will be done with random allocation software program. All groups will continue their routine medical treatments. All participants will be given subjects insoles and will be asked to use them for 24 weeks. Subjects in group 1 will continue their routine medical treatment for 12 weeks and will use insoles. Subjects in the 2nd group will be given only aerobic exercise training in addition to medical treatment and insoles, and the Subjects in the 3rd group will be given additional foot-ankle exercises for the 2nd group. Exercise training will continue for 12 weeks. For aerobic exercise training, Subjects will be walked on the treadmill three times a week. After the walking training, the Participants in the 3rd group will be given foot-ankle exercises. After 12 weeks of training, subjects will be followed for another 12 weeks. Participants will be evaluated before treatment, at 12 and 24 weeks. Evaluations and treatment will be done by different physical therapists. Physiotherapists making the assessment will not know which group the subjects are in.

Evaluations to be applied to the Subject:

Socio-demographic Form: In the first evaluation, socio-demographic information of subjects such as age, height, body weight will be obtained through a form. In addition to this information, the diabetes age of the subjects, the type of shoes used, the history of ulceration, the presence of other accompanying chronic diseases and their medications will be questioned.

Physical activity levels: It will be evaluated with the SenseWear Armband (SWA). Individuals will be asked to use two days a week and one day on the weekend. They will be asked to remove the device only while bathing. It is a small and lightweight device to be placed at the midpoint of the triceps muscle on the right arm. It has been developed to measure energy consumption more accurately by combining biaxial accelerometer and physical parameters. It includes motion and temperature sensors. It consists of biaxial accelerometer, skin temperature sensor, galvanic skin response and heat flux sensor. Body surface temperature will be evaluated with the skin temperature sensor, and skin impedance, which reflects the water content of the skin and the construction and dilatation of the vascular periphery, will be evaluated with the Galvanic Skin Response sensor. In addition, the rate of heat dissipation from the body will be evaluated with the Heat Flux Sensor, and the motion will be evaluated with the biaxial accelerometer. With the help of the program, personal information is entered on the screen, the calories consumed, the value in MET, the number of steps, rest, supine position and physical activity.

Evaluation of Foot Postures: Foot posture will be assessed by the Foot Posture Index (FPI).

Light Touch Pressure Sense Assessment: Plantar light touch-pressure sense is derived from 9 regions of Semmes-Weinstein® type (Baseline® Tactile), including heel, medial midfoot, lateral midfoot, 1st, 3rd and 5th metatarsal head and 1st, 3rd and 5th fingers. The Sensory Evaluator will be evaluated using 6 different monofilaments (levels: 2.83; 3.61; 4.31; 4.56; 5.07; 6.65), each of equal length (38 mm) and different diameters, applying standard pressure to the skin.

Blood values: Plasma glucose level, HbA1c, B 12, Urinary Albumin, CRP values will be taken in the medical analysis laboratory.

Neuropathy symptoms will be evaluated with the Douleur Neuropathique 4, Lanss Pain questionnaire.

Vibration test: Vibration sense will be evaluated quantitatively with a biotesiometer.

Stiffness assessment: It will be evaluated in continuous passive motion mode using an isokinetic dynamometer device (Humac Norm Isocynetic Dynanometer).

Plantar-Dorsiflexion Muscle Strength: Strength values of isokinetic ankle plantar flexor and dorsiflexor muscles will be measured by using an isokinetic dynamometer device (Humac Norm Isocynetic Dynanometer).

Plantar Pressure: Plantar pressures will be evaluated with a fixed pedobarograph (Medilogic, platform basic; Germany) and a 2-step protocol. Measurements will be recorded barefoot and for both feet separately. The sole of the foot will be divided into 10 regions (thumb, other fingers, 1st metatarsal head, 2nd metatarsal head, 3rd metatarsal head, 4th metatarsal head, 5th metatarsal head, lateral foot, medial and lateral heel). The peak pressure (N/cm2) in each zone will be noted.

Evaluation of foot function: Foot function will be evaluated using the Turkish version of the Foot Function Index (FFI). This questionnaire, which is used in foot and ankle problems, consists of 3 sub-headings and 23 items: foot pain level, disability and activity limitation.

Quality of life assessment: Turkish version of Nottingham Health Profile will be used.

All assessments will be made before treatment, at week 12, and week 24.

Interventions:

1. Group: Subjects will continue their routine medical treatments and will use custom made insoles for 24 weeks.
2. Group (Aerobic Exercises): Subjects will continue their routine medical treatments and will use custom made insoles for 24 weeks. In order to determine the exercise capacity of individuals, submaximal exercise test will be performed. Symptom-limited peak heart rates of individuals will be determined using the modified Bruce Protocol. For aerobic training, individuals 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 individual training programs every 2 weeks. Aerobic exercise will be done for 12 weeks, 3 days a week. Walking will be done for aerobic exercise. 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.
3. Group (Aerobic exercises+ Foot-related exercises): In addition to group 2, exercises that will increase the stretching, strengthening and sensory input for the ankles of the subjects will be given. Exercises for the foot and ankle will be done after the aerobic exercise is over. Aerobic exercise and foot related exercises will be done for 12 weeks, 3 days a week. Walking will be done for aerobic exercise.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes passive ankle stiffness compared with baseline and last measurement and Follow-up
timeFrame: Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 20 minutes.
Secondary outcomes:
measure: Changes Plantar Flexion and Dorsiflexion muscle strength compared with baseline and last measurement and Follow-up
timeFrame: Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 20 minutes.
measure: Changes Douleur Neuropathique 4 (DN4) compared with baseline and last measurement and Follow-up
timeFrame: Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 10 minutes.
measure: Changes plantar pressure compared with baseline and last measurement and Follow-up
timeFrame: Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 10 minutes.
measure: Changes foot function compared with baseline and last measurement and Follow-up
timeFrame: Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 5 minutes.
measure: Changes quality of life compared with baseline and last measurement and Follow-up
timeFrame: Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 5 minutes.
measure: Changes (Leeds Assesment of Neuropathic Symptoms and Signs (LANSS) compared with baseline and last measurement and Follow-up
timeFrame: Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 10 minutes.
measure: Changes Michigan Neuropathy Screening Instrument (MSNI) compared with baseline and last measurement and Follow-up
timeFrame: Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 10 minutes.
measure: Changes vibration test compared with baseline and last measurement and Follow-up
timeFrame: Subjects will be evaluated before treatment, at week 12, and week 24. The assessment takes approximately 15 minutes.
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Eastern Mediterranean University
state: Famagusta
Study officials:
affiliation: Eastern Mediterranean University
name: Cansu KOLTAK, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University
name: Yasin YURT, PhD
role: STUDY_DIRECTOR
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