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Completed

NCT Number: NCT03450200

Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy (DPN) is the common complication seen in the diabetic patients. Moreover, it will lead to another complication as disabilities and difficulties in activities of daily living (ADL). Most of the intervention for diabetes and diabetic neuropathic patients are mostly focusing on the prevention of foot ulcer. Diabetic foot care can prevent only for diabetes-related foot ulcer and foot amputation. It cannot be reduced DPN and cannot be improved the activities of daily living of the patient with DPN. Moreover, there is the restriction of weight-bearing exercise on the recommendation of exercises for the patients with DPN. Therefore, exercise program which may be suitable for all the patients with DPN was introduced in this study to improve ADL and decrease the neuropathic symptoms in the diabetic patients.

Compliance with exercise or intervention is not only critical to get adherence but also for the long-term use of its. Easy to do exercise in the short duration which can able to do on their own in their home promote their compliance and adherence to the exercises. In this study, the effectiveness of exercises in the patients with diabetic peripheral neuropathy was examined to fulfill the requirement of exercises which is simple and can be done in a short time. The objective of the study is to examine the effectiveness of exercise in the patients with diabetic peripheral neuropathy.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Okayama University

Okayama, 7008558, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients receiving diabetic care at the out-patient-department of designated hospitals, able to contact via the telephone, presence of signs and symptoms of DPN, agreed to involve in the study (informed consent), and aged over 25 years

Exclusion criteria

  • The persons who are suffering from DPN other than diabetes, severe illness of diabetic patients, diabetes with other comorbidities, amputation of hands and feet from any reasons, mental illness and alcoholism

Treatment and study plan

exercises for diabetic peripheral neuropathy

Other

Hands, fingers, and foot exercises for diabetic peripheral neuropathy to improve activities of daily living, and decreases the signs and symptoms of DPN

Health education for diabetic foot care

Other

Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.

Primary outcomes

  1. Change in Activities of daily living (ADLs) after intervention, at follow-up

    Time frame: eight weeks after intervention, eight weeks follow-up

    ADLs were measured by using Patient Neurotoxicity Questionnaire (PNQ).

  2. Change in signs of DPN after intervention, at follow-up

    Time frame: eight weeks after intervention, eight weeks follow-up

    DPN was assessed by using monofilament (SMW), Touch-TestTM Sensory Evaluator 5 Pieces Hand Kit of North Coast Medical Inc.

  3. Change in signs of DPN after intervention, at follow-up

    Time frame: eight weeks after intervention, eight weeks follow-up

    DPN was assessed by tuning fork vibration test.

Secondary outcomes

  1. Change in strength of hand grip

    Time frame: eight weeks after intervention, eight weeks follow-up

    Hand grip was measured in kilograms by using TTM original Dynamometer 100 kg.

  2. Change in strength of pinch force

    Time frame: eight weeks after intervention, eight weeks follow-up

    Key (lateral pinch) was measured by the gold standard B&L Engineering® Pinch Gauge 0-30 lb. in 1.0 lb.

  3. Change in walking speed

    Time frame: eight weeks after intervention, eight weeks follow-up

    Timed Up and Go (TUG) test was to measure the duration for walking in seconds.

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2018
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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