Effectiveness of Foot Exercise People With Type 2 Diabetes

NCT04064996 | Completed DMC

• 1 other identifier: 199292
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study will to investigate the effect of foot exercises in patients with type 2 diabetic and peripheral neuropathy. Subjects will be randomly allocated to either the control or intervention group. Data will be collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks; the control group will be received standard treatment but no exercises. The intervention and control groups will be examined and measured at the 4th and 8th weeks.

Conditions

Diabetes Mellitus, Type 2; Peripheral Neuropathy

Keywords

foot exercise; pain

Outcome Measures

Primary Outcomes (3)

• Pain assessment with Algometry

  An instrument for determining sensitivity to pain produced by pressure.

  Change from Baseline Pain at 8 weeks

• Pain assessment with The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale

  The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale evaluates sensory dysfunction and whether the pain is caused by neuropathic mechanisms or not. The LANSS comprises a 5-item questionnaire regarding pain symptoms and two items for clinical signs involving self-administered sensory tests for the presence of allodynia and decreased sensation to pinprick. Responses to each item are binary (yes or no) and each item is weighted differently depending on the odds ratio of a positive response to each item to predict that the pain is primarily neuropathic. The possible scores range from 0 to 24, with a score of 12 or greater considered to be suggestive of neuropathic pain

  Change from Baseline Pain at 8 weeks

• Pain assessment With Visual Analog Scale

  Participants are asked to mark the point where they feel their pain on a 10 centimeter (cm) horizontal line. 0-no pain, 10-unbearable pain. Night, activity and pain conditions are evaluated separately at rest.

  Change from Baseline Pain at 8 weeks

Secondary Outcomes (10)

• Muscle Strength with Hand held dynamometer

  1th day, 8th week

• Range Of Motion with goniometer

  1th day, 8th week

• Baseline Tactile Semmes-Weinstein Monofilament

  1th day, 8th week

• Edema measurement of tape

  1th day, 8th week

• Evaluation of functional capacity with 6 minutes walking test

  1th day, 8th week

Study Arms (2)

Group A

ACTIVE COMPARATOR

Routine rehabilitation program patient education

Other: Routine rehabilitation program patient education

Group B

EXPERIMENTAL

Routine rehabilitation program + foot exercise training

Other: Routine rehabilitation program + foot exercise training

Interventions

Routine rehabilitation program patient education OTHER

Patient education All the patients were assessed with Wagner Classification, Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, Visual Analogue Scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS), hand-held dynamometer, range of motion measurements, Semmes-Weinstein monofilament, two point discrimination test, circumference measurements, Foot and Ankle Ability Measure(FAAM), 6-minute walk test (6MWT) before and after the treatment.

Group A

Routine rehabilitation program + foot exercise training OTHER

In addition to the patient education , foot exercise training will be performed. Patients will be applied exercise training consisted of aerobic, strengthening, sensory training and stretching exercises for 3 days/week, 8 weeks. All the patients were assessed with Wagner Classification, Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, Visual Analogue Scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS) ,hand-held dynamometer,range of motion measurements, Semmes-Weinstein monofilament, two point discrimination test,circumference measurements, Foot and Ankle Ability Measure(FAAM), 6-minute walk test (6MWT) before and after the treatment.

Group B

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having type 2 diabetes mellitus for 5 years
• HbA1c \> among of between 6.5-10
• Having grade 0 or 1 phase of Wagner classification
• Diabetic neuropathy score ≥ 3

You may not qualify if:

• Not to know turkish
• Having hearing, visual and speaking problems
• Having (except diabetic neuropathy) other neurologic problems
• Having psychiatric and cognitive problems
• Having orthopedic, rheumatologic, cardiac, and pulmonary problems which stopping exercise

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Francia P, Gulisano M, Anichini R, Seghieri G. Diabetic foot and exercise therapy: step by step the role of rigid posture and biomechanics treatment. Curr Diabetes Rev. 2014 Mar;10(2):86-99. doi: 10.2174/1573399810666140507112536.

  PMID: 24807636 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Peripheral Nervous System Diseases; Pain

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evrim Koçarslan

  researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: August 17, 2019
• First Posted: August 22, 2019
• Study Start: April 1, 2019
• Primary Completion: July 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)