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

Primary Purpose

Hemodialysis, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation
resistive training program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Outpatient clinic faculty of physical therapy cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neuromuscular Electrical Stimulation group

resistive training group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

Assessing the change in physical and psychological fatigue
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)
Assessing the change in Dialysis efficiency
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).

Full Information

First Posted
October 6, 2023
Last Updated
October 18, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06079502
Brief Title
Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients
Official Title
Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular Electrical Stimulation group
Arm Type
Experimental
Arm Description
Thirty patients will receive a supervised program of intradialytic NMES two times per week for 16weeks with medical treatment.
Arm Title
resistive training group
Arm Type
Experimental
Arm Description
Thirty patients will receive a supervised program of intradialytic resistive training two times per week for 16weeks with medical treatment.
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation
Intervention Description
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
Other
Intervention Name(s)
resistive training program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessing the change in maximal strength of quadriceps and calf muscles
Description
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
Time Frame
at baseline and after 16 weeks of intervention
Title
Assessing the change in predicted peak vo2 max
Description
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).
Time Frame
at baseline and after 16 weeks of intervention
Secondary Outcome Measure Information:
Title
Assessing the change in physical and psychological fatigue
Description
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)
Time Frame
at baseline and after 16 weeks of intervention
Title
Assessing the change in Dialysis efficiency
Description
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).
Time Frame
at baseline and after 16 weeks of intervention

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asmaa Yacoub
Phone
+20 102 368 8443
Email
ptrservices2022@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa Yacoub
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic faculty of physical therapy cairo university
City
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa Yacoub
Phone
+20 102 368 8443
Email
ptrservices2022@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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