Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-04 @ 10:16 AM
Study NCT ID:
NCT00094250
Status:
WITHDRAWN
Last Update Posted:
2016-07-29
First Post:
2004-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HEARTS: Heart, Exercise, and Resistance Training Study
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
More Effective Exercise Modalities in Older Congestive Heart Failure Patients
Status:
WITHDRAWN
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was closed due to administrative reasons; study did not enroll any participants.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is enrolling patients with congestive heart failure (CHF). The goal of the study is to see if one of two carefully monitored exercise programs can improve the ability of these patients to function and get about their activities.
Detailed Description:
BACKGROUND:
The amount of functional skeletal muscle that CHF patients are able to preserve is a major independent predictor of their ability to maintain physical function. Older patients with CHF (who make up the vast majority of CHF patients) are least able to do this. The disease is marked by a loss of aerobic muscle fibers, while aging is marked by a loss of glycolytic muscle fibers. Because the disease may be physiologically different in older CHF patients than in younger ones (due to loss of both muscle types in older CHF patients), they need different therapeutic approaches. Strategy tests aimed at increasing muscle mass through resistance strength training in systolic failure patients have been rare, small, and generally lacking older participants. The studies done among younger CHF patients have shown that both aerobic, and combination aerobic and strength training can increase work capacity, oxidative muscle activity, and glycolytic muscle strength. Additionally, combination training can improve cardiac measures, including LVEF.
DESIGN NARRATIVE:
An estimated 200 participants age 65 and older with Class II and III CHF and LVEF 20% to 40% will be included in this study. Their work capacity will be measured in watts on a cycle ergometer exercise stress test (Time 1). They will be randomized by gender, race, and disease severity into two exercise groups: 1) resistance and aerobic training (RA); and 2) aerobic training (A). Both groups will exercise three times a week for 4 months. At the end of the 4 months of training, the cycle ergometer stress test will be repeated (Time 2). By comparing changes in maximum watts achieved from Time 1 to Time 2 in each group, an assessment can be made of the effectiveness of each exercise program in improving work capacity. Secondarily, measures will be performed and compared of myocardial remodeling, leg strength, and leg muscle oxidative capacity at Time 1 and Time 2. The goal of the study is to determine the following:
1. If low resistance frequent repetition resistance training combined with aerobic training increases aerobic work capacity more than pure aerobic training.
2. If any improvement in aerobic work capacity is due to changes in muscle fiber composition, local blood flow, arterial endothelial function, or some combination.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
The amount of functional skeletal muscle that CHF patients are able to preserve is a major independent predictor of their ability to maintain physical function. Older patients with CHF (who make up the vast majority of CHF patients) are least able to do this. The disease is marked by a loss of aerobic muscle fibers, while aging is marked by a loss of glycolytic muscle fibers. Because the disease may be physiologically different in older CHF patients than in younger ones (due to loss of both muscle types in older CHF patients), they need different therapeutic approaches. Strategy tests aimed at increasing muscle mass through resistance strength training in systolic failure patients have been rare, small, and generally lacking older participants. The studies done among younger CHF patients have shown that both aerobic, and combination aerobic and strength training can increase work capacity, oxidative muscle activity, and glycolytic muscle strength. Additionally, combination training can improve cardiac measures, including LVEF.
DESIGN NARRATIVE:
An estimated 200 participants age 65 and older with Class II and III CHF and LVEF 20% to 40% will be included in this study. Their work capacity will be measured in watts on a cycle ergometer exercise stress test (Time 1). They will be randomized by gender, race, and disease severity into two exercise groups: 1) resistance and aerobic training (RA); and 2) aerobic training (A). Both groups will exercise three times a week for 4 months. At the end of the 4 months of training, the cycle ergometer stress test will be repeated (Time 2). By comparing changes in maximum watts achieved from Time 1 to Time 2 in each group, an assessment can be made of the effectiveness of each exercise program in improving work capacity. Secondarily, measures will be performed and compared of myocardial remodeling, leg strength, and leg muscle oxidative capacity at Time 1 and Time 2. The goal of the study is to determine the following:
1. If low resistance frequent repetition resistance training combined with aerobic training increases aerobic work capacity more than pure aerobic training.
2. If any improvement in aerobic work capacity is due to changes in muscle fiber composition, local blood flow, arterial endothelial function, or some combination.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL071567 | NIH | None | https://reporter.nih.gov/quic… | View |