Physical Therapy for Liver Cirrhosis

• ClinicalTrials.gov Identifier: NCT04629456
• Recruitment Status: Completed
• First Posted: November 16, 2020
• Last Update Posted: November 16, 2020
• Sponsor: Cairo University
• Information provided by (Responsible Party): Manal k. youssef, Cairo University

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.

Condition or disease	Intervention/treatment	Phase
Liver Cirrhosis, Biliary	Other: neuromuscular electric stimulation; Other: Exercises	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Neuromuscular Electric Stimulation and Exercises Effect on Functional Exercise Performance and Quality of Life in Cases of Liver Cirrhosis
• Actual Study Start Date: January 7, 2020
• Actual Primary Completion Date: May 12, 2020
• Actual Study Completion Date: June 5, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Sitting standing test [ Time Frame: 12 week ]
   number of cycle /30 seconds
2. Balance [ Time Frame: 12 weeks ]
   Seconds
3. Time up and go test [ Time Frame: 12 weeks ]
   number of cycle / minute
4. 6 Minutes walk distance [ Time Frame: 12 weeks ]
   distance walked in 6 minutes
5. 2 Minutes steps test [ Time Frame: 12 weeks ]
   number of steps in 2 minutes.
6. Chronic liver diseases questionnaire (CLDQ) [ Time Frame: 12 week ]
   score
7. SF-36 [ Time Frame: 12 week ]
   Score

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Egypt

Manal K. youssef

Cairo, Egypt, 11528

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Manal K Youssef; Cairo university, Egypt

More Information

• Responsible Party: Manal k. youssef, Assistant professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04629456
• Other Study ID Numbers: P.T. REC/012/002609
• First Posted: November 16, 2020
• Last Update Posted: November 16, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data shared on reasonable request from corresponding author.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: 2 months
• Access Criteria: reasonable request from corresponding author.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manal k. youssef, Cairo University:

liver cirrhosis; exercises; neuromuscular electric stimulation; exercise capacity; quality of life

Additional relevant MeSH terms:

Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases