Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients

NCT ID: NCT06079502

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2024-07-30

Brief Summary

The aim of this study is to compare effect of intradialytic NMES versus resistive training on physical measures and fatigue in HDP.

Detailed Description

In this study we will compare between the effect of intradialytic neuromuscular electrical stimulation and resistive training on physical measures, dialysis efficiency and fatigue in HDP. This is first study that will compare between NMES and resistive training in HDP, investigating their effect on physical performance; dialysis efficiency and level of fatigue as previous studies show effect of each intervention alone.

Conditions

Hemodialysis; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Neuromuscular Electrical Stimulation group

Thirty patients will receive a supervised program of intradialytic NMES two times per week for 16weeks with medical treatment.

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type: DEVICE

A supervised program of intradialytic NMES of the quadriceps and calf muscles of both lower limbs with different phases, types and current intensity. The electrical stimulation program will included (total time, intensity, contraction-relaxation phase time): a toning program in the first two weeks.

resistive training group

Thirty patients will receive a supervised program of intradialytic resistive training two times per week for 16weeks with medical treatment.

Group Type: EXPERIMENTAL

resistive training program

Intervention Type: OTHER

Part one: Warming up for 5 minutes in the form of lower limbs range of motion (active free) exercise from supine position.

Part two: The main part is the resistive training for quadriceps and calf muscles from supine position using weights in the form of sand bags for 20 min.

Part three: Cooling down for 5 minutes in the form of lower limbs range of motion (active free) exercise from supine position.

The training parameters:

The exercise training will be done during the first 2 hours of HD session using free leg weights. The patient will assume a supine lying position on the treatment plinth and perform the exercises for every lower limb separately while the other limb will be supported on the plinth by therapist or the patient himself. Resistance will be placed at the malleoli level in the distal third of the leg.

Interventions

Neuromuscular Electrical Stimulation

A supervised program of intradialytic NMES of the quadriceps and calf muscles of both lower limbs with different phases, types and current intensity. The electrical stimulation program will included (total time, intensity, contraction-relaxation phase time): a toning program in the first two weeks.

Intervention Type: DEVICE

resistive training program

Part one: Warming up for 5 minutes in the form of lower limbs range of motion (active free) exercise from supine position.

Part two: The main part is the resistive training for quadriceps and calf muscles from supine position using weights in the form of sand bags for 20 min.

Part three: Cooling down for 5 minutes in the form of lower limbs range of motion (active free) exercise from supine position.

The training parameters:

The exercise training will be done during the first 2 hours of HD session using free leg weights. The patient will assume a supine lying position on the treatment plinth and perform the exercises for every lower limb separately while the other limb will be supported on the plinth by therapist or the patient himself. Resistance will be placed at the malleoli level in the distal third of the leg.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients of both sexes, with CKF on HD for more than 3 years.
• Age between 40 to 55 years old.
• BMI is between 25 and 29.9 kg/m2.

Exclusion Criteria

Patients who have one of the following contraindications to the interventions or affect the results

• Cognitive impairment that prevented them from performing the evaluations and who were unable to understand and sign the written informed consent.
• Stroke
• Smokers
• Anemic patients
• Osteoarticular or disabling musculoskeletal disorders
• Uncontrolled hypertension (systolic blood pressure>230 mm Hg and diastolic blood pressure>120 mm Hg)
• Patients with coronary artery disease or heart failure.
• Diabetic patients
• Infectious diseases and chest diseases
• Active smokers' patients with peripheral vascular disease in the lower limbs such as deep vein thrombosis or thromboangiitis

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Ibrahim Yacoub

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asmaa Yacoub

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Outpatient clinic faculty of physical therapy cairo university

Dokki, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Asmaa Yacoub

Role: CONTACT

ptrservices2022@gmail.com

+20 102 368 8443

Facility Contacts

Asmaa Yacoub

Role: primary

ptrservices2022@gmail.com

+20 102 368 8443

Other Identifiers

Asmaa_Yacoub

Identifier Type: -

Identifier Source: org_study_id