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Premature Fatigue in Veterans With Heart Failure: Neuronal Influences
EARLY_PHASE1 trial testing Electrical and Magnetic Nerve Stimulators in Heart Failure in 32 participants. Completed in 15 January 2017.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 32 |
| Start date | 1 July 2015 |
| Primary completion | 15 January 2017 |
| Estimated completion | 15 January 2017 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
Adults 20 to 75, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Following dynamic single leg knee extension exercise for a given duration (4-8 min), the decline in maximal voluntary contraction force will be measured.
| Group | Value | 95% CI |
|---|---|---|
| Patients With Heart Failure: Neuromuscular Abnormalities | -30 | ± 3 |
| Health Control Subjects and Neuromuscular Function | -5 | ± 2 |
During a 2-min maximal voluntary quadriceps contraction, central and peripheral fatigue will develop progressively and significantly more in HF vs. CTRLs.
| Group | Value | 95% CI |
|---|---|---|
| Patients With Heart Failure: Neuromuscular Abnormalities | -60 | ± 5 |
| Health Control Subjects and Neuromuscular Function | -35 | ± 6 |
| Group | Value | 95% CI |
|---|---|---|
| Patients With Heart Failure: Neuromuscular Abnormalities | -25 | ± 6 |
| Health Control Subjects and Neuromuscular Function | -20 | ± 5 |
Corticospinal responsiveness will be quantified before and after exercise.
| Group | Value | 95% CI |
|---|---|---|
| Patients With Heart Failure: Neuromuscular Abnormalities | -30 | ± 3 |
| Health Control Subjects and Neuromuscular Function | 10 | ± 8 |
A hallmark of patients with heart failure (HF) is premature fatigue which impairs their quality of life and depicts a major source of morbidity. Premature fatigue may be attributed to a) contraction-induced transient changes within muscles (i.e. peripheral fatigue) and/or b) failure of the central nervous system to 'drive' / activate locomotor muscles (i.e. central fatigue). Both determinants of fatigue can lead to a reduction in a muscle's force and power generating capacity and to a compromised ability to perform whole body activities (e.g. walking). Recent findings in health have documented that group III/IV afferent fibers from the working muscle play a critical role in the development of both components of fatigue. Specifically, group III/IV muscle afferents limit central motor drive (CMD) during exercise and thereby exaggerate the development of central fatigue. In contrast, muscle afferents optimize muscle O2 delivery through the precise regulation of circulation and ventilation during exercise and thereby attenuate the development of peripheral fatigue.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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