Liver Cirrhosis, BiliaryNCT04629456
Physical Therapy for Liver Cirrhosis
A study testing neuromuscular electric stimulation and Exercises in people with Liver Cirrhosis, Biliary, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 35 to 59 years
- Conditions the study is for
- Liver Cirrhosis, Biliary
- What is being tested?
- neuromuscular electric stimulation and Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2020to 5 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Cirrhosis, Biliary
- Being tested
- neuromuscular electric stimulation, Exercises
- Keywords
- liver cirrhosis, exercises, neuromuscular electric stimulation, exercise capacity, quality of life
- Medical subject headings
- Liver Cirrhosis, Biliary, Liver Cirrhosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electric stimulationOther
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.
ExercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sitting standing test
number of cycle /30 seconds
Measured: 12 week
Balance
Seconds
Measured: 12 weeks
Time up and go test
number of cycle / minute
Measured: 12 weeks
6 Minutes walk distance
distance walked in 6 minutes
Measured: 12 weeks
2 Minutes steps test
number of steps in 2 minutes.
Measured: 12 weeks
Chronic liver diseases questionnaire (CLDQ)
score
Measured: 12 week
SF-36
Score
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start7 Jan 2020
- Primary completion12 May 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cirrhosis, BiliaryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal k. youssef, Cairo University
- Investigators
- Manal K Youssef, Principal investigator, Cairo university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629456
- Sponsor's protocol ID
- P.T. REC/012/002609
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data shared on reasonable request from corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electric Stimulation and Exercises Effect on Functional Exercise Performance and Quality of Life in Cases of Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04629456
- Acronym / sponsor ID
- P.T. REC/012/002609
- Conditions
- Liver Cirrhosis, Biliary
- Keywords
- liver cirrhosis, exercises, neuromuscular electric stimulation, exercise capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: neuromuscular electric stimulationA 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 2 | Experimental | Other: ExercisesThe 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). |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular electric stimulationA 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 | group 1 |
| ExercisesThe 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 | Other | Group 2 |
Primary outcome
Sitting standing test
Time frame: 12 week
number of cycle /30 seconds
Balance
Time frame: 12 weeks
Seconds
Time up and go test
Time frame: 12 weeks
number of cycle / minute
6 Minutes walk distance
Time frame: 12 weeks
distance walked in 6 minutes
2 Minutes steps test
Time frame: 12 weeks
number of steps in 2 minutes.
Chronic liver diseases questionnaire (CLDQ)
Time frame: 12 week
score
SF-36
Time frame: 12 week
Score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Individual participant dataSharing planned: Yes. Data shared on reasonable request from corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal K Youssef principal investigator
Cairo university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular electric stimulation and Exercises in people with Liver Cirrhosis, Biliary, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sitting standing test (time frame: 12 week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.