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

NCT04965142 | Completed

• 1 other identifier: 20-5185
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Post-transplant metabolic syndrome (PTMS) affects about 50% liver transplant (OLT) and 25% lung transplant (LTx) recipients at 12-18 months post-transplant. PTMS (comprised of glucose intolerance, obesity, hypercholesterolemia and hypertension) has been associated with increased risk for cardiovascular morbidity and long-term survival. Exercise studies in the early post-transplant period have shown some benefits on PTMS risk factors with facility-based training, but it remains unclear if exercise can be sustained in the home environment with sufficient adherence or training intensity to impact PTMS beyond the early post-transplant period. Objectives: 1) To evaluate the feasibility of a three-month individualized, virtual home-based exercise training program in OLT and LTx recipients starting at 1 year post-transplant. 2) To assess estimates of intervention efficacy on elements of PTMS, insulin resistance, exercise self-efficacy, and health related quality of life (HRQL). Methods: 20 OLT and 20 LTx recipients with 2 or more PTMS risk factors at 12-18 months post-transplant will be randomized to a home-based exercise program versus usual care. The exercise group will undergo aerobic training 3 to 5 times per week with resistance training at least twice weekly over a 12-week period. Exercises will be demonstrated by a qualified exercise professional during the first visit with weekly phone and video calls to guide exercise progression, ease communication and promote exercise self-efficacy and adherence based on guiding behavioral principles. As secondary measures, PTMS, insulin resistance, body composition (optional), HRQL, and assessment of self-efficacy will be assessed at baseline and 12-weeks.

Conditions

Metabolic Syndrome

Keywords

Lung Transplant Recipients; Liver Transplant Recipients; Exercise Training

Outcome Measures

Primary Outcomes (6)

• Recruitment

  We will measure recruitment-success percentage and will record reasons for non-participation.

  When recruitment is complete (approximately 18 months after study initiation)

• Adherence to Exercise Training

  Adherence to the home-based exercise program (aerobic and resistance) will be measured through an exercise diary completed by participants and reviewed through weekly communication.

  Over a 12 week period

• Study Retention

  Retention will be assessed by measuring attrition throughout the intervention period.

  Over a 12 week period

• Adverse Events During Exercise Training (Safety and Tolerability)

  Adverse events with exercise training will be assessed throughout the study period.

  Over a 12 week period

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

  Multiple choice and free form questionnaire assessing the participants' satisfaction with the home exercise program and study intervention.

  Change over the study period assessed at weeks 2, 6, and 12

• Participant Satisfaction with Study Participation (Control Group)

  Multiple choice and free form questionnaire assessing participants' satisfaction with the study intervention.

  12 weeks from baseline assessment

Secondary Outcomes (16)

• Total Cholesterol

  Change from baseline at 12 weeks

• Triglycerides

  Change from baseline at 12 weeks

• High Density Lipoprotein

  Change from baseline at 12 weeks

• Low Density Lipoprotein

  Change from baseline at 12 weeks

• Fasting Blood Glucose Levels

  Change from baseline at 12 weeks

Other Outcomes (4)

• Liver Fibrosis

  Change from baseline at 12 weeks

• Fat Free Mass Index

  Change from baseline at 12 weeks

• Body Fat Mass Index

  Change from baseline at 12 weeks

Study Arms (2)

Home Exercise Group

EXPERIMENTAL

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.

Behavioral: Exercise Training

Control Group

NO INTERVENTION

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

Interventions

Exercise Training BEHAVIORAL

The intervention group will be asked to complete aerobic exercises 3 to 5 times per week (≥ 150 minutes of at least moderate aerobic intensity) and resistance training at least twice a week over a 12-week period.

Home Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult lung and liver transplant recipients 12 to 18 months post-transplant
• Presence of 2 or more metabolic risk factors (hypertension, hyperlipidemia, diabetes, obesity)

You may not qualify if:

• 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)
• Neuro-muscular disease or orthopedic limitations
• Physically active with ≥ 150 minutes/week of moderate-intensity aerobic physical activity
• Residing outside the province of Ontario

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian National Transplant Research Program: collaborator
• University of Toronto: collaborator

Study Sites (1)

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• Rozenberg D, Santa Mina D, Nourouzpour S, Camacho Perez E, Stewart BL, Wickerson L, Tsien C, Selzner N, Shore J, Aversa M, Woo M, Holdsworth S, Prevost K, Park J, Azhie A, Huszti E, McLeod E, Dales S, Bhat M. 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 Res Protoc. 2022 Mar 23;11(3):e35700. doi: 10.2196/35700.

  PMID: 35319467 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dmitry Rozenberg, MD PhD

  University Health Network /University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Lung and liver transplant recipients will be randomized to home exercise group versus usual care group.

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 16, 2021
• Study Start: August 19, 2021
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)