Effect of Hydrotherapy On Pain, Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy

NCT ID: NCT07260214

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-03-01

Brief Summary

The current study aims to investigate the effects of hydrotherapy compared to land-based training on patients with diabetic peripheral neuropathy. It will evaluate hydrotherapy's impact on pain relief, sensation improvement, balance, and overall quality of life for these patients.

Detailed Description

Hydrotherapy training is a rehabilitative approach proposed for different medical conditions, the hydrotherapy environment facilitates patients with functional limitations, who feel a safer setting and are consequently more motivated to the training. The physical properties of water help to improve patient stability and to allow limbs movements by offloading the body weight and Exerting resistance against the body segments and giving proprioceptive inputs.

Moreover, the warmth of hydrotherapy pool helps muscle relaxation and seems to reduce pain perception, aiming to improve blood circulation so that nutrients can be distributed more smoothly to body tissues, strengthen small muscles, calves, and thighs, as well as address joint mobility limitations often experienced by diabetes mellitus patients.

Several authors evaluated hydrotherapy therapy as possible gait and balance training of neurological patients and demonstrated beneficial effects mostly in Parkinson's disease and stroke. Limited number of studies, even if affected by small sample sizes, made a comparison between hydrotherapy training and on land training. Showing best balance results of the former for the same diseases.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydrotherapy training

This group will consist of seventeen diabetic peripheral neuropathy patients will perform hydrotherapy training for 12 weeks.

Group Type: EXPERIMENTAL

Hydrotherapy training

Intervention Type: OTHER

The patients will participate in hydrotherapy sessions three days per week for 12 weeks in a heated swimming pool maintained at 32°C. Each session will include a sequence of activities: relaxation and breath control, balance exercises, gait training, and hydrotherapy cycling.

Land training

This group will consist of seventeen diabetic peripheral neuropathy patients will do land training for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Land training

Intervention Type: OTHER

The patients do the same exercise of the experimental group on land three days per week for 12 weeks.

Interventions

Hydrotherapy training

The patients will participate in hydrotherapy sessions three days per week for 12 weeks in a heated swimming pool maintained at 32°C. Each session will include a sequence of activities: relaxation and breath control, balance exercises, gait training, and hydrotherapy cycling.

Intervention Type: OTHER

Land training

The patients do the same exercise of the experimental group on land three days per week for 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of diabetic peripheral neuropathy due to type 2 diabetes mellitus of both sex Patients must have confirmed diagnosis of diabetic peripheral neuropathy based on clinical symptoms (E.G, numbness, tingling and burning pain) and diagnostic test such as nerve conduction studies
• Chronicity of type 2 diabetes mellitus more than 10 years
• Age range: between 40-65years old
• Stable Blood Glucose Levels HbA1c (≤5.7)
• No active infections or wound

Exclusion Criteria

• Severe Renal Impairment.
• Uncontrolled cardiovascular diseases
• Pregnancy
• Neurological or musculoskeletal conditions
• Inability to safely enter or exit the pool
• Uncontrolled infections
• Vitamin B12 deficiency.
• Postural hypotension

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Aya Yasser Saber Mahmoud

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamer Ibrahim Abo Elyazed, PhD

Role: STUDY_CHAIR

Assistant Professor, Beni-Suef University

Reham Ali Mohamed Ali, PhD

Role: STUDY_DIRECTOR

Lecturer, Beni-Suef University

Ahmed Moheyeldien Hamed, PhD

Role: STUDY_DIRECTOR

Lecturer, Beni-Suef University

Locations

Beni-Suef university hospital

Banī Suwayf, , Egypt

Countries

Egypt

Central Contacts

Aya Yasser Saber Mahmoud, B.Sc

Role: CONTACT

Ayayassersaber@gmail.com

+201559406122

Tamer Ibrahim Abo Elyazed, PhD

Role: CONTACT

Facility Contacts

Aya Yasser Saber Mahmoud, B.Sc

Role: primary

Ayayassersaber@gmail.com

+201559406122

Other Identifiers

FPTBSUREC/0305/2325

Identifier Type: -

Identifier Source: org_study_id