Clinical trial NCT04064996: Effectiveness of Foot Exercise People With Type 2 Diabetes
Official title: Effectiveness of Foot Exercise Training on Patients With Type 2 Diabetes and Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Peripheral Neuropathy
Keywords: foot exercise
pain
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Purpose of our study investigation of the effects foot exercises in patients with type 2 diabetic and peripheral neuropathy.

Excepted results: Routine treatment + foot exercises pain, flexibility, edema, muscle strength, sensation, quality of life we believe that there will be good progress in peripheral neuropathy effects, Leeds assessment of neuropathic symptoms and signs(LANSS) results.

In this context, it is planned that patients randomly divided into 2 groups. Group 1 control group. Group 2 intervention group. Patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks. The patients will be evaluated by clinical measurements and scales based on patient notification at the 4th and 8th weeks.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain assessment with Algometry
timeFrame: Change from Baseline Pain at 8 weeks
measure: Pain assessment with The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
timeFrame: Change from Baseline Pain at 8 weeks
measure: Pain assessment With Visual Analog Scale
timeFrame: Change from Baseline Pain at 8 weeks
Secondary outcomes:
measure: Muscle Strength with Hand held dynamometer
timeFrame: 1th day, 8th week
measure: Range Of Motion with goniometer
timeFrame: 1th day, 8th week
measure: Baseline Tactile Semmes-Weinstein Monofilament
timeFrame: 1th day, 8th week
measure: Edema measurement of tape
timeFrame: 1th day, 8th week
measure: Evaluation of functional capacity with 6 minutes walking test
timeFrame: 1th day, 8th week
measure: Two Point Discrimation Test
timeFrame: 1th day, 8th week
measure: The Foot and Ankle Ability Measure
timeFrame: 1th day, 8th week
measure: HbA1c
timeFrame: 1 th day, 8th week
measure: Serum creatinine
timeFrame: 1 th day, 8th week
measure: Albumin levels
timeFrame: 1 th day, 8th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: researcher
name: Evrim Koçarslan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.