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Exercise Intervention - and Impact on Hospitalization

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Mayo Clinic

Status

Terminated

Conditions

Debility Due to Disease
Sarcopenia

Treatments

Other: placebo
Behavioral: exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03106220
16-010102

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

19 participants in 2 patient groups, including a placebo group

home exercise
Active Comparator group
Description:
participate in home exercise program
Treatment:
Behavioral: exercise
standard care
Placebo Comparator group
Description:
encouraged to join physical therapy and walking goals
Treatment:
Other: placebo

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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