What side effects are associated with this type of intervention?

Common treatments for frailty, such as structured exercise programs, including telemedicine-based home exercise, generally have minor side effects. These may include mild muscle or joint pain, which are typically temporary and manageable. Serious adverse events are rare and usually not directly attributable to the exercise intervention. Overall, these programs are considered safe and beneficial for improving physical capacity and reducing frailty.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs solely for the treatment of frailty. However, exercise programs, including those delivered via telemedicine, have been recognized for their benefits in improving physical function and reducing frailty. These programs often focus on structured physical activity, which can enhance overall health and potentially impact conditions like liver disease through improved circulation and fitness. While the FDA has approved various medications for conditions that may contribute to frailty (e.g., osteoporosis, sarcopenia), the primary approach remains non-pharmacological, emphasizing exercise and lifestyle modifications.

What other types of research exist?

Promising, novel alternatives to a telemedicine-based structured home exercise program for frailty patients include: 1) Supervised exercise programs, which provide structured and monitored physical activity; 2) High-intensity interval training (HIIT), which has been effective in improving cardiovascular and muscular health; 3) Multidisciplinary rehabilitation programs, which combine physical therapy, occupational therapy, and other interventions to address multiple aspects of frailty. These alternatives can offer comprehensive and effective approaches to improving exercise capacity and reducing frailty.

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Home Exercise Program for Heart Condition

N/A

Recruiting

Led By Jesse Hansen, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (baseline), week 26 (final visit)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a home exercise program using telemedicine for people with a specific heart condition called Fontan physiology. The goal is to improve their fitness and reduce barriers to accessing exercise programs. Participants will get online support to help them stay active. Exercise training has been shown to increase exercise capacity in survivors of Fontan surgery.

Who is the study for?

This trial is for adults with Fontan heart physiology who can exercise and aren't on IV heart drugs. It's not for those with severe heart issues seen in recent echocardiograms, under 130 cm tall, pregnant or planning pregnancy during the study, or have noncardiac conditions that could affect participation.

What is being tested?

The trial tests a home exercise program delivered via telemedicine to see if it improves frailty and exercise capacity in people with Fontan physiology. It also examines whether this approach overcomes barriers to access and affects liver disease markers associated with Fontan.

What are the potential side effects?

Since the intervention involves an exercise program, potential side effects may include typical workout-related discomforts such as muscle soreness or fatigue. However, specific risks related to individuals' pre-existing health conditions will be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (baseline), week 26 (final visit)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (baseline), week 26 (final visit)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline), week 26 (final visit) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Frailty score by the Fried frailty instrument

Secondary study objectives

Change in Alanine Aminotransferase (ALT)

Change in Aspartate Transferase (AST)

Fibrosis

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Home exercise programExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home exercise program

2017

Completed Phase 3

~870

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for frailty, such as structured exercise programs, work primarily by improving muscle strength, cardiovascular health, and overall physical function. These programs often include aerobic exercises, resistance training, and flexibility exercises. The mechanisms of action include enhanced muscle protein synthesis, increased blood flow, and improved metabolic function. For frailty patients, these improvements are crucial as they lead to better mobility, reduced risk of falls, and enhanced ability to perform daily activities. In the context of a telemedicine-based structured home exercise program, these benefits are particularly significant as they provide accessible, consistent, and guided physical activity, which can help overcome barriers related to socioeconomic and geographic factors. Additionally, improved overall health and circulation may positively impact markers of associated conditions, such as liver disease.

Adverse events and safety issues associated with physical activity and exercise for adults with osteoporosis and osteopenia: A systematic review of observational studies and an updated review of interventional studies.