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

Not Applicable

Recruiting

• Conditions: Hemodialysis; Fatigue
• Interventions: Device: Neuromuscular Electrical Stimulation; Other: resistive training program

• Registration Number: NCT06079502
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-12
• Last Update Submitted: 2023-10-18
• Study Start: 2023-10-20
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-05-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuromuscular Electrical Stimulation group	Neuromuscular Electrical Stimulation	Thirty patients will receive a supervised program of intradialytic NMES two times per week for 16weeks with medical treatment.
resistive training group	resistive training program	Thirty patients will receive a supervised program of intradialytic resistive training two times per week for 16weeks with medical treatment.

Primary Outcome Measures

Name	Time	Method
Assessing the change in maximal strength of quadriceps and calf muscles	at baseline and after 16 weeks of intervention	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
Assessing the change in predicted peak vo2 max	at baseline and after 16 weeks of intervention	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).

Secondary Outcome Measures

Name	Time	Method
Assessing the change in Dialysis efficiency	at baseline and after 16 weeks of intervention	At baseline and 16 weeks after the intervention, blood samples will be collected after at least 12 h of fasting, and before the HD session, from an antecubital vein via venipuncture. Dialysis efficiency (represented using Kt/V) will be calculated from body weight and blood urea nitrogen (BUN) levels before and after dialysis using the Daugirdas formula as follows. Single-pool Kt/V will be calculated monthly using urea kinetic modeling equations derived from the following equation: (post: pre-dialysis plasma BUN ratio to estimate k. T/v and npcr: mathematical modeling) (second-generation logarithmic estimates of single-pool variable volume kt/v: an analysis of error). Kt/V = - ln(R - 0.008 × t) + \[(4-3.5 × R) × UF/W\], where R is the ratio of post-dialysis to pre-dialysis serum BUN concentration, t is the duration of hemodialysis in hours, UF is the amount of ultrafiltration (in l) during the HD session, and W is the post-dialysis weight (in kg).
Assessing the change in physical and psychological fatigue	at baseline and after 16 weeks of intervention	Chalder Fatigue Questionnaire (CFQ11): is a short questionnaire, phrased in simple English with a straightforward answering system, it provides a brief tool to measure both physical and psychological fatigue. It consists from 11 items are answered on a 4-point scale ranging from the asymptomatic to maximum symptomology, a score of 0, increasing to 1, 2 or 3 as they become more symptomatic. The respondent's global score can range from 0 to 33. The global score also spans two dimensions physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11)

Trial Locations

Locations (1)

Outpatient clinic faculty of physical therapy cairo university; 🇪🇬 Dokki, Egypt