Physical Therapy for Liver Cirrhosis

NCT04629456 | Completed

• 1 other identifier: P.T. REC/012/002609
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis, Biliary

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Interventions

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.

group 1

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

Group 2

Eligibility Criteria

• Age: 35 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Manal K. youssef

Cairo, 11528, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Liver Cirrhosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Manal K Youssef

  Cairo university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: January 7, 2020
• Primary Completion: May 12, 2020
• Study Completion: June 5, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 2 months
• Access Criteria: reasonable request from corresponding author.

Locations

EG (1)