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

NCT ID: NCT05668325

Last Updated: 2022-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-01-03

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.

Conditions

Diabetic Polyneuropathy; Diabetic Foot; Type 2 Diabetes

Keywords

Behavior; Diabetic foot; Diabetic polyneuropathy; Exercise; Range of motion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mini trampoline exercise group

"Structured Patient Information Form" and "Foot care behavior scale", "5.07/10 g Semmes-Weinstein Monofilament", "128 Hz Manual Electronic Tunnel" and "Goniometer" were applied to the patients as a pre-test and recorded in the patient registry. related forms. Afterwards, diabetic foot care information was given to the patients and "Diabetic Foot Care Information Brochure" was given. Afterwards, the patients were visited for a total of 24 times a week, three days a week for eight weeks. At the first visit, the patients were informed about the exercise program and then the "Home-based Mini Trampoline Exercise Information Brochure" was given to the patients. The patients were given an exercise program three times a week, a total of 24 times for eight weeks. In addition, the "Foot Monitoring Form" was applied to the patients once a week. Apart from the "Structured Patient Information Form", other data collection tools were applied to this patient group as a post-test.

Group Type: EXPERIMENTAL

Mini trampoline exercise group

Intervention Type: OTHER

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

Data collection tools were applied to this group of patients before the study. Diabetic foot care information was given and "Diabetic Foot Care Information Brochure" was given. A total of eight home visits were made for eight weeks, once a week, and the "Foot Monitoring Form" was applied. At the end of eight weeks, all data collection tools except the "Structured Patient Information Form" were applied again.

Group Type: EXPERIMENTAL

Control group

Intervention Type: OTHER

In this study, patients were visited at home once a week for eight weeks and their feet were checked.

Interventions

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.

Intervention Type: OTHER

Control group

In this study, patients were visited at home once a week for eight weeks and their feet were checked.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

Buket DAŞTAN

Lecturer phd

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bayburt University

Bayburt, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

RCS16956037

Identifier Type: -

Identifier Source: org_study_id