Clinical trial NCT05668325: The Effect of Mini Trampoline Exercise Program on Diabetic Foot Care Behavior and Polyneuropathy
Official title: INVESTIGATION OF THE EFFECT OF HOME BASED MINI TRAMBOLINE EXERCISE PROGRAM ON DIABETIC FOOT CARE BEHAVIOR AND DIABETIC POLYNEUROPATHY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Polyneuropathy
Diabetic Foot
Type 2 Diabetes
Keywords: Behavior
Diabetic foot
Diabetic polyneuropathy
Exercise
Range of motion
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The number of samples was determined by using the G\*Power 3.1.9.6 program with a 95% confidence interval of 0.05 error rate, a study in which the effects of the mini trampoline exercise program performed with diabetic polyneuropathy patients on foot mobility and foot sensation in the literature were evaluated, with a power of 80% and an effect size of 0.90. calculated. As a result of the statistical analysis, it was found that a total of 28 patients, 14 in the mini trampoline exercise group and 14 in the control group, should be included in the study. Considering that if the sample size increases, the standard error will decrease and the working power will increase, each group was increased by 43% and a total of 40 patients were included in the study, 20 patients for each group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to examine the effect of home-based mini trampoline exercise program on diabetic foot care behavior and diabetic polyneuropathy in Type 2 diabetes patients.

Detailed description: Diabetes Mellitus (DM) is a rapidly increasing metabolic disease in the world. It is stated that the incidence of DM, one of the most important public health problems, is increasing much faster than in the past, and it is estimated that approximately 592 million people will be affected worldwide by 2035. Diabetic foot; represents a range of complications caused by a combination of neuropathy and varying degrees of vascular disease in diabetic patients, including lower extremity infection, ulcer formation, and/or deep tissue damage. Diabetic foot is the cause of approximately 75-85% of all lower extremity amputations. Diabetic foot is also the leading cause of non-traumatic lower extremity amputations worldwide. Diabetic polyneuropathy is a peripheral neuropathy characterized by symmetrical sensory symptoms such as numbness, paresthesia, pain and muscle weakness predominantly in the distal parts of the arms and legs. Diabetic neuropathy is one of the most common complications of diabetes and its lifetime prevalence exceeds 50%, especially in Type 2 diabetes patients.

Prevention of diabetic foot is possible by adopting healthy foot care behaviors and applying examination methods that evaluate foot health. It is reported that it is important to evaluate autonomic neuropathy symptoms (skin dryness, hydration, color) and motor neuropathy symptoms (weakening of the inner foot muscles, foot deformities) in the foot examination of the patients. In addition, it is stated that the diabetic polyneuropathy symptom of the patients should be measured using the "semmes-weinstein 10 g monofilament" protective sense, the "128 Hz tuning fork" vibration perception and the "goniometer" to measure the ankle and 1st metatarsophalangeal joint (MTPJ) mobility. There are important findings on the effectiveness of regular physical activity in the prevention of primary and secondary development of diabetes and diabetic foot. Today, supervised exercise programs in the home environment are supported to ensure the continuity of exercise of the patients and the demand for exercises that can be applied at home is increasing. Exercise programs performed at home under the supervision of a professional provide a structured program, increase self-motivation through feedback, and encourage participants to exercise. In the literature, it is stated that supervised foot exercises, together with a health-promoting program, effectively reduce the symptoms of diabetic neuropathy, improve vibration perception and joint mobility of the foot and ankle, redistribute pressure during walking, and increase foot strength and function. These positive effects also reduce the risk factors for the development of foot ulcers in diabetes.

While there are guidelines and studies on exercise practice in diabetes management in Turkey, there are gaps in the literature and practices regarding diabetic foot care behaviors and foot exercises in diabetic polyneuropathy. Therefore, it would be beneficial to explore alternative, easy exercises to manage diabetes and prevent/delay diabetic foot complications and promote care. In this study, it was aimed to examine the effect of home-based mini trampoline exercise program on foot care behaviors and diabetic polyneuropathy in Type 2 diabetes patients.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Type 2 diabetes and diabetic polyneuropathy for at least one year,
* Having a body mass index between 18-30 kg/m2,
* Being literate,
* Being residing in XXXX province,
* Was determined as agreeing to participate in the study.

Exclusion Criteria:

* Having a history of malignancy,
* Myocardial infarction, stroke, liver failure/renal failure, foot/leg amputation,
* Current or previous foot ulcer,
* History of surgery on the knee, ankle or hip, major vascular complications and/or severe retinopathy,
* Dementia or not being able to give consistent information,
* Doing regular exercise such as walking, running or foot exercise,
* Receiving physiotherapy at any time of the study.

Primary outcomes:
measure: Patient Information Form
timeFrame: 8 week.
measure: Foot Care Behavior Scale
timeFrame: 8 week.
measure: Foot Tracking Form
timeFrame: 8 week.
measure: Home Based Mini Trampoline Exercise Tracking Form
timeFrame: 8 week.
Secondary outcomes:
Other outcomes:
Locations:
city: Bayburt
country: Turkey
facility: Bayburt University
state: Merkez
Study officials:
References: