Physical Therapy for Liver Cirrhosis

Liver Cirrhosis, Biliary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04629456
• Other study ID #: P.T. REC/012/002609
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: June 5, 2020

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 5, 2020
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Biliary

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Manal K. youssef	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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