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NCT03106220 Clinical Trial

Exercise Intervention - and Impact on Hospitalization

Sarcopenia Clinical Trial

Official title:
Exercise Intervention and Its Impact on Hospitalization - a Mulitcentered Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03106220
Other study ID # 16-010102
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date January 14, 2021

Study information
Verified date February 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in patients with end-stage liver disease. The presence of these complications portends poor prognosis. The purpose of this study is to assess the impact of a formal home based video strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of this exercise program on complication rates, hospitalization, on quality of life (QOL) and on survival.

Recruitment information / eligibility
Status Terminated
Enrollment 19
Est. completion date January 14, 2021
Est. primary completion date January 14, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility inclusion= waitlisted for liver transplant with poor 6MWT Exclusion criteria include: age < 18 years, recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month, large esophageal varices without primary prophylaxis, active excessive alcohol intake (in the previous 3 months), current overt uncontrolled hepatic encephalopathy, hepatopulmonary syndrome with uncontrolled hypoxia, portopulmonary hypertension, inability to perform exercise, or marked symptomatic comorbidities (cardiac, pulmonary, renal). multiorgan transplant

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• exercise
home exercise program
Other:
• placebo
encourage walking and physical therapy per standard care.

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 6MWT 6 minute walk 3 months
Primary hand grip hand grip 3 months
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