Response of Cardiovascular Parameters to Physical Therapy Post Liver Transplantation
1 other identifier
interventional
30
1 country
1
Brief Summary
Liver transplantation (LT) is the only life-saving treatment option in patients with advanced liver disease. Deceased-donor LT is not frequent but is increasing in Asian countries. Because current liver allocation policies follow the severity principle wherein patients at highest risk for mortality receive top priority, anesthesiologists may face severely ill patients more frequently with deceased-donor LT than with living-donor LT. In this regard, with the outstanding surgical success of recent LT, cardiovascular complications have emerged as the leading cause of death after LT, particularly among those with advanced liver cirrhosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedAugust 24, 2022
August 1, 2022
3 years
August 23, 2022
August 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Heart rate
Heart rate monitors can assess a person's heart rate and reveal whether it is high or low. Heart rate Trusted Source is a "clinical indicator of overall cardiac health," and it can also help a person determine their performance during a workout. Six minute walk test: It will be carried out before and after interventions to determine the patients functional capacity (in the 7th.day \&in the 21st.day.) It will be used as a training tool as well as an assessment tool.
3 weeks
Blood pressure
It will be carried out before and after interventions to determine the patients functional capacity (in the 7th.day \&in the 21st.day.) It will be used as a training tool as well as an assessment tool.
3 weeks
Study Arms (2)
Heart rate
ACTIVE COMPARATORHeart rate monitors can assess a person's heart rate and reveal whether it is high or low. Heart rate Trusted Source is a "clinical indicator of overall cardiac health," and it can also help a person determine their performance during a workout.
Blood pressure
ACTIVE COMPARATORIt will be carried out before and after interventions to determine the patients functional capacity (in the 7th.day \&in the 21st.day.) It will be used as a training tool as well as an assessment tool.
Interventions
Heart rate monitors can assess a person's heart rate and reveal whether it is high or low. Heart rate Trusted Source is a "clinical indicator of overall cardiac health," and it can also help a person determine their performance during a workout. Six minute walk test: It will be carried out before and after interventions to determine the patients functional capacity (in the 7th.day \&in the 21st.day.) It will be used as a training tool as well as an assessment tool. They will receive conventional physical therapy program which includes deep breathing exercise in form of (diaphragmatic, apical and costal breathing), Training about right way of cough and early ambulation from bed for 3 sessions / week, twice daily for 21 days.
Eligibility Criteria
You may qualify if:
- Age ranged from 40 to 60
- All patients will be medically stable.
- All patients will have the same medical care (fluid and electrolyte management in the ICU, immunosuppressive, prophylactic) the patient might also require (antihypertensive medications, insulin or oral hypoglycemic agents, mild analgesics).
You may not qualify if:
- Patients with neurological and neuromuscular disease.
- Total liver transplantation.
- Cardiac disease.
- Alcoholic hepatitis.
- Blind individuals.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
El Sahel Teaching Hospital
Cairo, Egypt
Related Publications (4)
Watt KD, Pedersen RA, Kremers WK, Heimbach JK, Charlton MR. Evolution of causes and risk factors for mortality post-liver transplant: results of the NIDDK long-term follow-up study. Am J Transplant. 2010 Jun;10(6):1420-7. doi: 10.1111/j.1600-6143.2010.03126.x. Epub 2010 May 10.
PMID: 20486907BACKGROUNDZaky A, Bendjelid K. Appraising cardiac dysfunction in liver transplantation: an ongoing challenge. Liver Int. 2015 Jan;35(1):12-29. doi: 10.1111/liv.12582. Epub 2014 Jun 5.
PMID: 24797833BACKGROUNDWong F, Liu P, Lilly L, Bomzon A, Blendis L. Role of cardiac structural and functional abnormalities in the pathogenesis of hyperdynamic circulation and renal sodium retention in cirrhosis. Clin Sci (Lond). 1999 Sep;97(3):259-67.
PMID: 10464050BACKGROUNDKwon HM, Jun IG, Jung KW, Moon YJ, Shin WJ, Song JG, Hwang GS. Pretransplant Resting Heart Rate and Its Association With All-Cause Mortality in Liver Transplant Recipients. Transplant Proc. 2017 Jun;49(5):1092-1096. doi: 10.1016/j.transproceed.2017.03.043.
PMID: 28583534BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omnia Saeed, PhD
October University for Modern Sciences and Arts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.Omnia Saeed Mahmoud Ahmed
Study Record Dates
First Submitted
August 23, 2022
First Posted
August 24, 2022
Study Start
April 17, 2019
Primary Completion
March 30, 2022
Study Completion
April 1, 2022
Last Updated
August 24, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share