Physical Therapy for Liver Cirrhosis

Neuromuscular Electric Stimulation and Exercises Effect on Functional Exercise Performance and Quality of Life in Cases of Liver Cirrhosis

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis, Biliary
• Intervention / Treatment: Other: neuromuscular electric stimulation; Other: Exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11528
    • Manal K. youssef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; 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.	Other: neuromuscular electric stimulation; 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.
Experimental: Group 2; 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).	Other: Exercises; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sitting standing test	number of cycle /30 seconds	12 week
Balance	Seconds	12 weeks
Time up and go test	number of cycle / minute	12 weeks
6 Minutes walk distance	distance walked in 6 minutes	12 weeks
2 Minutes steps test	number of steps in 2 minutes.	12 weeks
Chronic liver diseases questionnaire (CLDQ)	score	12 week
SF-36	Score	12 week

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Manal K Youssef, Cairo university, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): May 12, 2020
• Study Completion (Actual): June 5, 2020

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; exercise capacity; liver cirrhosis; neuromuscular electric stimulation; exercises
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Fibrosis; Liver Cirrhosis; Liver Cirrhosis, Biliary
• Other Study ID Numbers: P.T. REC/012/002609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No