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Home Exercise Program for Metabolic Syndrome

N/A

Recruiting

Led By Dmitry Rozenberg, MD PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult lung and liver transplant recipients 12 to 18 months post-transplant

Presence of 2 or more metabolic risk factors (hypertension, hyperlipidemia, diabetes, obesity)

Must not have

Neuro-muscular disease or orthopedic limitations

Active cardiovascular disease (recent heart attack, significant coronary artery disease on cardiac catheterization, heart failure, uncontrolled arrhythmias, chest pain, dizziness, or fainting in the last 3 months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the feasibility and efficacy of a home-based exercise program for people who have had a liver or lung transplant and are at risk for post-transplant metabolic syndrome.

Who is the study for?

This trial is for adult lung and liver transplant recipients who are 12 to 18 months post-transplant with at least two metabolic risk factors like high blood pressure, high cholesterol, diabetes, or obesity. It's not for those with neuro-muscular diseases, orthopedic limitations, already very active individuals, people living outside Ontario or those with recent serious heart issues.

What is being tested?

The study tests a three-month home-based exercise program's feasibility and its impact on Post-transplant Metabolic Syndrome (PTMS). Participants will do aerobic exercises several times a week plus resistance training twice weekly. They'll get guidance from an exercise professional through phone and video calls.

What are the potential side effects?

Since the intervention involves regular exercise training designed by professionals according to individual capabilities, significant side effects are not expected. However, participants may experience typical workout-related discomforts such as muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a lung or liver transplant 1 to 1.5 years ago.

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I have two or more conditions like high blood pressure, high cholesterol, diabetes, or obesity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a muscle or bone condition that limits my movement.

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I have had serious heart problems or symptoms in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 2, 6, and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 2, 6, and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 2, 6, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to Exercise Training

Adverse Events During Exercise Training (Safety and Tolerability)

Participant Satisfaction with Exercise Training and Study Participation (Exercise Group)

+3 more

Secondary study objectives

C-peptide Levels

C-reactive Protein Levels

Fasting Blood Glucose Levels

+13 more

Other study objectives

Body Fat Mass Index

Electrocardiogram

Fat Free Mass Index

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Home Exercise GroupExperimental Treatment1 Intervention

The home-based exercise group will be asked to exercise 3 to 5 times per week (≥ 150 minutes of aerobic exercises (i.e. walking, cycling, or treadmill) of at least moderate intensity) and to also complete resistance training (resistance bands or free weights) at least twice weekly over a 12-week period supervised by an exercise professional. The resistance training will be personalized, aiming for 6 to 10 exercises targeting the major muscle groups, progressing to 3 sets of 8 to 12 repetitions. Exercise prescriptions will be developed and monitored by an exercise professional with weekly follow-up meetings and supported with a web application (Physiotec) that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials. Participants will receive one counselling session on healthy eating and physical activity at the start of the study along with an exercise manual.

Group II: Control GroupActive Control1 Intervention

Participants will receive one counselling session on healthy eating and physical activity at the start of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Training

2011

Completed Phase 3

~1470

0 / 4Eligibility criteria met