Back to resultsModified Foot Exercise to Improve Sensitivity and Perfussion on Type 2 Diabetes Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Smart Foot Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring foot exercise, Diabetes Mellitus type 2
Eligibility Criteria
Inclusion Criteria:
- Diabetes Mellitus Type 2
Exclusion Criteria:
- Chronic Heart Failure
- Chronic Kidney Diseae
Sites / Locations
- RS UNS (Universitas Sebelas Maret Hospital)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Smart Foot Exercise
Arm Description
The patient lies supine (supine) with the legs raised 450 while supported for 1-3 minutes until blanching occurs (the skin becomes pale). The patient sits on the edge of the bed with the legs hanging down and then performs dorsiflexion, plantarflexion, inversion, and eversion for 3 minutes until the skin appears red. The patient lies supine with the legs covered with a blanket for 3-5 minutes. This whole cycle is repeated 3-6 times per session, and each session is repeated 2-4 times a day. Movement using newspaper media, namely by: Place a sheet of newspaper on the floor, then shape the sheet into a ball with both feet. The ball shape is then opened into a sheet as before with both feet. Tear the newspaper into two parts, and separate the two parts of the newspaper. Tear the first newspaper into small pieces with both feet. Remove the bunch of stubs and place them in a second, whole newspaper. Wrap everything into a ball shape with both feet. This step is enough to do once.
Outcomes
Primary Outcome Measures
Fasting Blood Glucose
Fasting Blood Glucose
Monofilament test
Monofilament test to detect diabetic neuropathy
Ankle Brachial Index
Ankle Brachial Index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05408234
Brief Title
Modified Foot Exercise to Improve Sensitivity and Perfussion on Type 2 Diabetes Patients
Official Title
Modified Foot Exercise to Improve Peripheral Perfussion and Sensitivity on Type 2 Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sebelas Maret
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Subject will be trained to do regular foot exercise during their visit to the clinic. We will evaluate foot sensitivity and peripheral perfussion after
Detailed Description
Use an 8-10 MHz Doppler probe with a gel smeared over the sensor. Place the Doppler probe on the pulse area at a 45-60° angle to the skin surface.
Move the probe to find the most precise and robust arterial pulse before inflating the cuff.
The cuff is inflated about 20 mm Hg above the point where the arterial Doppler sound disappears.
Then slowly deflate until the Doppler sound reappears and records this value. The blood pressure at which the arterial pulse reappears is the systolic pressure for that blood vessel.
If the flow is still detected at the maximum inflation rate (300 mmHg), the cuff should be deflated immediately to avoid pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
foot exercise, Diabetes Mellitus type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
The study was conducted in the control and treatment groups where the control group will get the treatment of doing modified leg exercises for one week. The control group did not get the modified leg exercise. Both groups received standard therapy for type 2 diabetes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Smart Foot Exercise
Arm Type
Experimental
Arm Description
The patient lies supine (supine) with the legs raised 450 while supported for 1-3 minutes until blanching occurs (the skin becomes pale).
The patient sits on the edge of the bed with the legs hanging down and then performs dorsiflexion, plantarflexion, inversion, and eversion for 3 minutes until the skin appears red.
The patient lies supine with the legs covered with a blanket for 3-5 minutes. This whole cycle is repeated 3-6 times per session, and each session is repeated 2-4 times a day.
Movement using newspaper media, namely by:
Place a sheet of newspaper on the floor, then shape the sheet into a ball with both feet.
The ball shape is then opened into a sheet as before with both feet. Tear the newspaper into two parts, and separate the two parts of the newspaper. Tear the first newspaper into small pieces with both feet. Remove the bunch of stubs and place them in a second, whole newspaper. Wrap everything into a ball shape with both feet. This step is enough to do once.
Intervention Type
Other
Intervention Name(s)
Smart Foot Exercise
Intervention Description
The patient lies supine (supine) with the legs raised 450 while supported for 1-3 minutes until blanching occurs (the skin becomes pale).
The patient sits on the edge of the bed with the legs hanging down and then performs dorsiflexion, plantarflexion, inversion, and eversion for 3 minutes until the skin appears red.
The patient lies supine with the legs covered with a blanket for 3-5 minutes. This whole cycle is repeated 3-6 times per session, and each session is repeated 2-4 times a day.
Movement using newspaper media, namely by:
Place a sheet of newspaper on the floor, then shape the sheet into a ball with both feet.
The ball shape is then opened into a sheet as before with both feet. Tear the newspaper into two parts, and separate the two parts of the newspaper. Tear the first newspaper into small pieces with both feet. Remove the bunch of stubs and place them in a second, whole newspaper. Wrap everything into a ball shape with both feet. This step is enough to do once.
Primary Outcome Measure Information:
Title
Fasting Blood Glucose
Description
Fasting Blood Glucose
Time Frame
Cange Fasting Blood Glucose in 1 weeks
Title
Monofilament test
Description
Monofilament test to detect diabetic neuropathy
Time Frame
Cange monofilament test in 1 weeks
Title
Ankle Brachial Index
Description
Ankle Brachial Index
Time Frame
Cange Ankle Brachial Index in 1 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetes Mellitus Type 2
Exclusion Criteria:
Chronic Heart Failure
Chronic Kidney Diseae
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nurhasan Agung Prabowo, MD
Phone
6282328010430
Email
dr.Nurhasan21@staff.uns.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurhasan Agung Prabowo, MD
Organizational Affiliation
Universitas Sebelas Maret
Official's Role
Principal Investigator
Facility Information:
Facility Name
RS UNS (Universitas Sebelas Maret Hospital)
City
Surakarta
State/Province
Central Java
ZIP/Postal Code
57145
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nurhasan Agung Prabowo, MD
Phone
082328010430
Email
dr.Nurhasan21@staff.uns.ac.id
12. IPD Sharing Statement
Plan to Share IPD
No
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Modified Foot Exercise to Improve Sensitivity and Perfussion on Type 2 Diabetes Patients
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