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

NCT06079502 | Unknown DMC

• 1 other identifier: Asmaa_Yacoub
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemodialysis; Fatigue

Outcome Measures

Primary Outcomes (2)

• Assessing the change in maximal strength of quadriceps and calf muscles

  By using a Hand held dynamometer: A Kern-type standardized traction dynamometer (Kern CH50 50KG dynamometer) will used to assess the maximal strength of quadriceps and calf muscles will estimate. The patient will remain seated in a fixed chair so the back will supported on the back rest with the hip and knee at 90°, the subject will be asked to exert the greatest possible force without holding the chair with his/her arms,the values of muscular strength variables will be the mean of 3 consecutive measurements obtained by the same investigator to minimize errors

  at baseline and after 16 weeks of intervention

• Assessing the change in predicted peak vo2 max

  By using a 6-minute walk test (6MWT): It consisted of measuring the maximum distance covered during a 6 min period at an active pace, along a 20 m corridor near the HD unit. At the end of the test period, the total distance travelled was recorded by means of a standardized odometer,that will be used to calculate predicted peak vo2 by using the following equation Mean Peak VO2( ml /kg/min)= 4. 948+ 0. 023\*Mean 6 MWD (meters) (SEE 1.1 ml/ kg/ min), standard error of estimate (SEE).

  at baseline and after 16 weeks of intervention

Secondary Outcomes (2)

• Assessing the change in physical and psychological fatigue

  at baseline and after 16 weeks of intervention

• Assessing the change in Dialysis efficiency

  at baseline and after 16 weeks of intervention

Study Arms (2)

Neuromuscular Electrical Stimulation group

EXPERIMENTAL

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

Device: Neuromuscular Electrical Stimulation

resistive training group

EXPERIMENTAL

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

Other: resistive training program

Interventions

Neuromuscular Electrical Stimulation 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.

Neuromuscular Electrical Stimulation group

resistive training program 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.

resistive training group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic faculty of physical therapy cairo university

Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Asmaa Yacoub

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa Yacoub

CONTACT

+20 102 368 8443; ptrservices2022@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: October 20, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

EG (1)