The Effect of Mini Trampoline Exercise Program on Diabetic Foot Care Behavior and Polyneuropathy

Type 2 Diabetes Clinical Trial

Official title:

INVESTIGATION OF THE EFFECT OF HOME BASED MINI TRAMBOLINE EXERCISE PROGRAM ON DIABETIC FOOT CARE BEHAVIOR AND DIABETIC POLYNEUROPATHY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05668325
• Other study ID #: RCS16956037
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 3, 2022

Study information

• Verified date: December 2022
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 3, 2022
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies
• Type 2 Diabetes

Intervention

Other:
• Mini trampoline exercise group
In this study, patients performed a 30-45 minute mini-trampoline exercise program 3 times a week for eight weeks (two months) under the supervision of the investigator.
• Control group
In this study, patients were visited at home once a week for eight weeks and their feet were checked.

Locations

Country	Name	City	State
Turkey	Bayburt University	Bayburt	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Information Form	This form included 15 questions to determine the sociodemographic characteristics of the patients (age, BMI, gender, marital status, education level, occupation, income perception level, smoking status) and disease-related characteristics.; The mini-trampoline exercise group was administered to the patients twice before the study and at the end of the 8th week.	8 week.
Primary	Foot Care Behavior Scale	It was created by Borges in 2007 with the aim of improving foot self-care behaviors in diabetes. The one-dimensional scale consists of 15 items; The items consist of a five-point Likert scale. The scale score is calculated as the lowest 15 and the highest 75 points. An increase in the score obtained from the scale indicates that the patient's self-care behaviors are better.; The mini-trampoline exercise group was administered to the patients twice before the study and at the end of the 8th week.	8 week.
Primary	Foot Tracking Form	It was created by the researcher to use in the foot follow-up of patients by scanning the literature on diabetic foot. in form; "Washing, drying, moisturizing, foot control, socks change, shoe change, shoe control, foot positioning and nail cutting", which includes the foot care behaviors of the patients, took place.; It was applied to the patients once every week, a total of 8 times.	8 week.
Primary	Home Based Mini Trampoline Exercise Tracking Form	The home-based mini trampoline exercise monitoring form was created by the researcher to be used in the follow-up of the patients' home-based mini trampoline exercise program by scanning the literature on mini trampoline exercises. In form; each patient-specific exercise day, exercise time, exercise duration, exercise break time, and post-exercise foot control were included.; It was applied to the patients once every week, a total of 8 times.	8 week.