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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Debility Due to Disease
• Sarcopenia

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

External Links

•   Mayo Clinic Clinical Trials