Effectiveness of Foot Exercise People With Type 2 Diabetes

Istanbul University

Status: Completed

Conditions: Peripheral Neuropathy; Diabetes Mellitus, Type 2

Treatments: Other: Routine rehabilitation program patient education; Other: Routine rehabilitation program + foot exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT04064996

199292

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Group A

Active Comparator group

Description:

Routine rehabilitation program patient education

Treatment:

Other: Routine rehabilitation program patient education

Group B

Experimental group

Description:

Routine rehabilitation program + foot exercise training

Treatment:

Other: Routine rehabilitation program + foot exercise training