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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

C-peptide Levels

C-reactive Protein Levels

Fasting Blood Glucose Levels

+13 more

Other outcome measures

Body Fat Mass Index

Electrocardiogram

Fat Free Mass Index

+1 more

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

~1440

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,474 Previous Clinical Trials

485,002 Total Patients Enrolled

4 Trials studying Metabolic Syndrome

167 Patients Enrolled for Metabolic Syndrome

Canadian National Transplant Research ProgramOTHER

8 Previous Clinical Trials

1,540 Total Patients Enrolled

University of TorontoOTHER

690 Previous Clinical Trials

1,019,603 Total Patients Enrolled

22 Trials studying Metabolic Syndrome

918 Patients Enrolled for Metabolic Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participation in this medical experiment?

"Affirmative, the information published on clinicaltrials.gov suggests that this experiment is presently recruiting participants. It was initially declared on August 19th 2021 and updated for the last time in November 25th 2022. 40 volunteers need to be acquired from a single medical centre."

Answered by AI

What is the aim of this experimental endeavor?

"This medical trial will measure study retention over a 12-week period. Secondary outcomes include self-efficacy with exercise training (Exercise Group), triglyceride levels, and c-peptide levels among participants on insulin therapy. The Exercise Self-Efficacy Scale ranges from 0% to 100%, where higher scores denote greater confidence in their ability to undertake physical activities and exercise."

Answered by AI

Are any slots still available in this research project?

"Affirmative. According to the information on clinicaltrials.gov, this medical research is currently enrolling individuals with its first posting being dated August 19th 2021 and most recent update done November 25th 2022. The endeavor requires 40 participants to be sourced from a single site."

Answered by AI

Recent research and studies

JMIR Research ProtocolsJournal

Feasibility of a Home-based Exercise Program for Managing Posttransplant Metabolic Syndrome in Lung and Liver Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial

Rozenberg, Dmitry, Daniel Santa Mina, Sahar Nourouzpour, Encarna Camacho Perez, Brooke Lyn Stewart, Lisa Wickerson, Cynthia Tsien, et al.. 2022. “Feasibility of a Home-based Exercise Program for Managing Posttransplant Metabolic Syndrome in Lung and Liver Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/35700.

clinicaltrials.govStudy

Feasibility of a Home Exercise Program to Manage Post-transplant Metabolic Syndrome

2021. "Feasibility of a Home Exercise Program to Manage Post-transplant Metabolic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04965142.

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