Back to resultsPhysical Therapy for Liver Cirrhosis
Primary Purpose
Liver Cirrhosis, Biliary
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
neuromuscular electric stimulation
Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis, Biliary focused on measuring liver cirrhosis, exercises, neuromuscular electric stimulation, exercise capacity, quality of life
Eligibility Criteria
Inclusion Criteria:
- Positive for anti-HCV.
- Not under antiviral therapy at entry.
- Positive for chronic hepatitis or compensated cirrhosis.
- Negative for hepatitis B surface (HBs) antigen.
- Free of co-infection with HIV.
- Not pregnant.
- Systolic blood pressure of less than 180 mmHg or diastolic blood pressure of less than 110 mmHg.
- (viii)No ischemic heart disease or severe arrhythmia
Exclusion Criteria:
- Significant cardiac disease (ejection fraction <60% or history of coronary artery disease).
- Chronic renal failure on dialysis.
- Hemoglobin <11.0 g/L.
- Human immunodeficiency virus infection.
- Hepatocellular carcinoma.
- Active non-hepatocellular carcinoma related malignancy.
- Myopathy.
- Any physical impairment or orthopedic abnormality preventing EX, or post-liver transplantation
Sites / Locations
- Manal K. youssef
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group 1
Group 2
Arm Description
A total of eight electrodes were placed on the quadriceps femoris muscles (four on each leg): two on the vastus medialis, one on the rectus femoris muscle, and one on the vastus lateralis muscle. The stimulation protocol of the NMES consisted of a symmetrical biphasic square pulse at 75 Hz, a duty cycle of 6 seconds (sec.) on and 29 sec. off, a pulse time of 410 sec. during a session lasting 20 min. The intensity was increased to maximum individual toleration. The muscle contractions were visible and palpable.
The chair-seated exercises were used in the early stages of the program because the participants were frail adults. Repetitions of toe raises, heel raises, knee lifts, knee extensions, and others were performed while seated on a chair. Hip flexions, lateral leg raises, and repetitions of other exercises were performed standing upright behind the chair and holding the back of the chair for stability. To strengthen lower extremities, a fixed weight was placed on the ankle while participants performed strengthening exercises. Weights of 0.50, 0.75, 1.00, and 1.50 kg were used in accordance with each participant's strength level as the resistance progressively increased. The exercises performed using these ankle weights included seated knee flexion and extension and standing knee flexion and extensions. Exercises using a resistance band: Resistance bands were used to strengthen lower body. Lower body exercises included leg extension and hip flexion(24).
Outcomes
Primary Outcome Measures
Sitting standing test
number of cycle /30 seconds
Balance
Seconds
Time up and go test
number of cycle / minute
6 Minutes walk distance
distance walked in 6 minutes
2 Minutes steps test
number of steps in 2 minutes.
Chronic liver diseases questionnaire (CLDQ)
score
SF-36
Score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04629456
Brief Title
Physical Therapy for Liver Cirrhosis
Official Title
Neuromuscular Electric Stimulation and Exercises Effect on Functional Exercise Performance and Quality of Life in Cases of Liver Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
May 12, 2020 (Actual)
Study Completion Date
June 5, 2020 (Actual)
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
5. Study Description
Brief Summary
Patients with liver cirrhosis have severe physical deconditioning. Aim: To compare between the effect of neuromuscular electric stimulation(NMES) and exercises (EX)on treatment of patients with liver cirrhosis.
Detailed Description
70 patients have been chosen from department of internal medicine, Cairo university hospitals, Egypt. 5 patients refused to participate .65 patients divided randomly into 2 groups. All the procedures were explained to patients.2 patients refused to sign informed consent and excluded from the study. 31 patients in group1 and 32 patients in group2. 1patients dropped in group1 and excluded from the study and two patients didn't continued the programmed treatment in group 2 and their data removed.
Thirty patients in each group signed an informed consent and complete the treatment program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Biliary
Keywords
liver cirrhosis, exercises, neuromuscular electric stimulation, exercise capacity, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
A total of eight electrodes were placed on the quadriceps femoris muscles (four on each leg): two on the vastus medialis, one on the rectus femoris muscle, and one on the vastus lateralis muscle. The stimulation protocol of the NMES consisted of a symmetrical biphasic square pulse at 75 Hz, a duty cycle of 6 seconds (sec.) on and 29 sec. off, a pulse time of 410 sec. during a session lasting 20 min. The intensity was increased to maximum individual toleration. The muscle contractions were visible and palpable.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
The chair-seated exercises were used in the early stages of the program because the participants were frail adults. Repetitions of toe raises, heel raises, knee lifts, knee extensions, and others were performed while seated on a chair. Hip flexions, lateral leg raises, and repetitions of other exercises were performed standing upright behind the chair and holding the back of the chair for stability. To strengthen lower extremities, a fixed weight was placed on the ankle while participants performed strengthening exercises. Weights of 0.50, 0.75, 1.00, and 1.50 kg were used in accordance with each participant's strength level as the resistance progressively increased. The exercises performed using these ankle weights included seated knee flexion and extension and standing knee flexion and extensions. Exercises using a resistance band: Resistance bands were used to strengthen lower body. Lower body exercises included leg extension and hip flexion(24).
Intervention Type
Other
Intervention Name(s)
neuromuscular electric stimulation
Intervention Description
A total of eight electrodes were placed on the quadriceps femoris muscles (four on each leg): two on the vastus medialis, one on the rectus femoris muscle, and one on the vastus lateralis muscle. The stimulation protocol of the NMES consisted of a symmetrical biphasic square pulse at 75 Hz, a duty cycle of 6 seconds (sec.) on and 29 sec. off, a pulse time of 410 sec. during a session lasting 20 min. The intensity was increased to maximum individual toleration. The muscle contractions were visible and palpable.
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
The chair-seated exercises were used in the early stages of the program because the participants were frail adults. Repetitions of toe raises, heel raises, knee lifts, knee extensions, and others were performed while seated on a chair. Hip flexions, lateral leg raises, and repetitions of other exercises were performed standing upright behind the chair and holding the back of the chair for stability. To strengthen lower extremities, a fixed weight was placed on the ankle while participants performed strengthening exercises. Weights of 0.50, 0.75, 1.00, and 1.50 kg were used in accordance with each participant's strength level as the resistance progressively increased. The exercises performed using these ankle weights included seated knee flexion and extension and standing knee flexion and extensions. Exercises using a resistance band: Resistance bands were used to strengthen lower body. Lower body exercises included leg extension and hip flexion
Primary Outcome Measure Information:
Title
Sitting standing test
Description
number of cycle /30 seconds
Time Frame
12 week
Title
Balance
Description
Seconds
Time Frame
12 weeks
Title
Time up and go test
Description
number of cycle / minute
Time Frame
12 weeks
Title
6 Minutes walk distance
Description
distance walked in 6 minutes
Time Frame
12 weeks
Title
2 Minutes steps test
Description
number of steps in 2 minutes.
Time Frame
12 weeks
Title
Chronic liver diseases questionnaire (CLDQ)
Description
score
Time Frame
12 week
Title
SF-36
Description
Score
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive for anti-HCV.
Not under antiviral therapy at entry.
Positive for chronic hepatitis or compensated cirrhosis.
Negative for hepatitis B surface (HBs) antigen.
Free of co-infection with HIV.
Not pregnant.
Systolic blood pressure of less than 180 mmHg or diastolic blood pressure of less than 110 mmHg.
(viii)No ischemic heart disease or severe arrhythmia
Exclusion Criteria:
Significant cardiac disease (ejection fraction <60% or history of coronary artery disease).
Chronic renal failure on dialysis.
Hemoglobin <11.0 g/L.
Human immunodeficiency virus infection.
Hepatocellular carcinoma.
Active non-hepatocellular carcinoma related malignancy.
Myopathy.
Any physical impairment or orthopedic abnormality preventing EX, or post-liver transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal K Youssef
Organizational Affiliation
Cairo university, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manal K. youssef
City
Cairo
ZIP/Postal Code
11528
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data shared on reasonable request from corresponding author.
IPD Sharing Time Frame
2 months
IPD Sharing Access Criteria
reasonable request from corresponding author.
Learn more about this trial
Physical Therapy for Liver Cirrhosis
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