Modified Foot Exercise to Improve Sensitivity and Perfussion on Type 2 Diabetes Patients

NCT05408234 | Unknown Phase 1 DMC

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

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

Conditions

Diabetes Mellitus, Type 2

Keywords

foot exercise, Diabetes Mellitus type 2

Outcome Measures

Primary Outcomes (3)

• Fasting Blood Glucose

  Fasting Blood Glucose

  Cange Fasting Blood Glucose in 1 weeks

• Monofilament test

  Monofilament test to detect diabetic neuropathy

  Cange monofilament test in 1 weeks

• Ankle Brachial Index

  Ankle Brachial Index

  Cange Ankle Brachial Index in 1 weeks

Study Arms (1)

Smart Foot Exercise

EXPERIMENTAL

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.

Other: Smart Foot Exercise

Interventions

Smart Foot Exercise OTHER

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.

Smart Foot Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes Mellitus Type 2

You may not qualify if:

• Chronic Heart Failure
• Chronic Kidney Diseae

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

RS UNS (Universitas Sebelas Maret Hospital)

Surakarta, Central Java, 57145, Indonesia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nurhasan Agung Prabowo, MD

  Universitas Sebelas Maret

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurhasan Agung Prabowo, MD

CONTACT

6282328010430; dr.Nurhasan21@staff.uns.ac.id

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: June 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)