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Completed

NCT Number: NCT04629456

Physical Therapy for 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.

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Key information

Conditions

Liver Cirrhosis, Biliary Behavior Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

35 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manal K. youssef

Cairo, 11528, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neuromuscular electric stimulation

Other

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

Other

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 16, 2020
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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