Diabetic PolyneuropathyNCT05668325
The Effect of Mini Trampoline Exercise Program on Diabetic Foot Care Behavior and Polyneuropathy
A study testing Mini trampoline exercise group in people with Diabetic Polyneuropathy and Diabetic Foot, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Polyneuropathy, Diabetic Foot, Type 2 Diabetes
- What is being tested?
- Mini trampoline exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 3 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INVESTIGATION OF THE EFFECT OF HOME BASED MINI TRAMBOLINE EXERCISE PROGRAM ON DIABETIC FOOT CARE BEHAVIOR AND DIABETIC POLYNEUROPATHY
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.
Read the 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
- Being tested
- Mini trampoline exercise group, Control group
- Keywords
- Behavior, Diabetic foot, Diabetic polyneuropathy, Exercise, Range of motion
- Medical subject headings
- Diabetic Neuropathies, Diabetic Foot, Diabetes Mellitus, Type 2, Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini trampoline exercise groupOther
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 groupOther
In this study, patients were visited at home once a week for eight weeks and their feet were checked.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start1 Mar 2021
- Primary completion3 Nov 2021
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket DAŞTAN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668325
- Sponsor's protocol ID
- RCS16956037
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I'll decide later
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION OF THE EFFECT OF HOME BASED MINI TRAMBOLINE EXERCISE PROGRAM ON DIABETIC FOOT CARE BEHAVIOR AND DIABETIC POLYNEUROPATHY
- ClinicalTrials.gov ID
- NCT05668325
- Acronym / sponsor ID
- RCS16956037
- Conditions
- Diabetic Polyneuropathy, Diabetic Foot, Type 2 Diabetes
- Keywords
- Behavior, Diabetic foot, Diabetic polyneuropathy, Exercise, Range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mini trampoline exercise group | Experimental | Other: 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. |
| Control group | Experimental | Other: Control groupData 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini trampoline exercise groupIn 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. | Other | Mini trampoline exercise group |
| Control groupIn this study, patients were visited at home once a week for eight weeks and their feet were checked. | Other | Control group |
Primary outcome
Patient Information Form
Time frame: 8 week.
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.
Foot Care Behavior Scale
Time frame: 8 week.
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.
Foot Tracking Form
Time frame: 8 week.
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.
Home Based Mini Trampoline Exercise Tracking Form
Time frame: 8 week.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: Undecided. I'll decide later
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini trampoline exercise group in people with Diabetic Polyneuropathy and Diabetic Foot, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form (time frame: 8 week.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.