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Exercise Intervention - and Impact on Hospitalization

Primary Purpose

Sarcopenia, Debility Due to Disease

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

exercise

placebo

About this trial

This is an interventional prevention trial for Sarcopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Arizona
Mayo Clinic in Florida
Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

home exercise

standard care

Arm Description

participate in home exercise program

encouraged to join physical therapy and walking goals

Outcomes

Primary Outcome Measures

6MWT

6 minute walk

hand grip

Secondary Outcome Measures

Full Information

NCT ID

NCT03106220

First Posted

March 30, 2017

Last Updated

March 3, 2021

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03106220

Brief Title

Exercise Intervention - and Impact on Hospitalization

Official Title

Exercise Intervention and Its Impact on Hospitalization - a Mulitcentered Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

slow patient accrual

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

January 14, 2021 (Actual)

Study Completion Date

January 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia, Debility Due to Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

home exercise vs standard care with cross-over

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

home exercise

Arm Type

Active Comparator

Arm Description

participate in home exercise program

Arm Title

standard care

Arm Type

Placebo Comparator

Arm Description

encouraged to join physical therapy and walking goals

Intervention Type

Behavioral

Intervention Name(s)

exercise

Intervention Description

home exercise program

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

encourage walking and physical therapy per standard care.

Primary Outcome Measure Information:

Title

6MWT

Description

6 minute walk

Time Frame

3 months

Title

hand grip

Description

hand grip

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kymberly D Watt

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Mayo Clinic in Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

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Exercise Intervention - and Impact on Hospitalization

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