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

NCT05668325 | Completed DMC

• 1 other identifier: RCS16956037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Polyneuropathy; Diabetic Foot; Type 2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Mini trampoline exercise group

EXPERIMENTAL

"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.

Other: Mini trampoline exercise group

Control group

EXPERIMENTAL

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.

Other: Control group

Interventions

Mini trampoline exercise group 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.

Mini trampoline exercise group

Control group OTHER

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

Control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Bayburt University

Bayburt, Merkez, 69 000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetic Foot; Diabetes Mellitus, Type 2; Behavior; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The block randomization method was applied. The coin flip method was used to determine the exercise and control groups, and the exercise group was determined as A and the control group B. In our study, in which octal blocking was performed with four A and four B blocks in each block, the possible number of blocks was calculated as 70. Five numbers between 1 and 70 were generated (for 40 people, it is enough to choose five random blocks) using the "in randomear" command in Excel, and the numbers 27, 11, 13, 18, 51 were obtained. Patients were randomized according to the blocks corresponding to these numbers. In addition, in the "post-hoc" power analysis performed at the end of the study, the power of the study was determined to be 85%, and this result showed that the sample size of the study was sufficient.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer phd

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 29, 2022
• Study Start: March 1, 2021
• Primary Completion: November 3, 2021
• Study Completion: January 3, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

TU (1)