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The effect of exercise on coagulation in patients with continuous flow blood pumps

The effect of exercise on von Willebrand factor in patients with continuous flow left ventricular assist device

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000594123
Enrollment
45
Registered
2019-04-17
Start date
2019-07-01
Completion date
2022-06-30
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The goal of this pilot study is to evaluate whether exercise can reverse the acquired von Willebrand syndrome occurs in patients with continuous-flow left ventricular assist device (CF-LVAD). We hypothesis that increasing pulsatility (vasoconstriction process) through performing active exercise might preserve vital coagulation protein (vWF) from excessive degradation and even restore normal vWF profile. This is a prospective, single-centre observational pilot study designed to assess the effect of exercise on the recovery of a vital coagulation protein vWF in patients supported with CF-LVAD (n = 15) compare to heart transplant patients (previously requiring a CF-LVAD) (n=15) and healthy volunteers (n =15).

Interventions

To investigate the relationship between exercises and changes of von Willebrand factor profile in adult patients with left ventricular assist device. This is a prospective, single-centre observational pilot study. Exercise therapy is part of the standard care for all LVAD and heart transplant patients in the first period after their discharge from the hospital. To be considered for the study, the patients need to be medically stable, and be able to tolerate minimum 30 minutes of exercise at mo

To investigate the relationship between exercises and changes of von Willebrand factor profile in adult patients with left ventricular assist device. This is a prospective, single-centre observational pilot study. Exercise therapy is part of the standard care for all LVAD and heart transplant patients in the first period after their discharge from the hospital. To be considered for the study, the patients need to be medically stable, and be able to tolerate minimum 30 minutes of exercise at moderate intensity. After consent is obtained – blood will be collected pre / post exercise once per week for 5 weeks. Blood samples will be taken over 5 weeks in order to correlate changes in coagulation blood profile pre and post exercise with increases in patient’s overall fitness post-LVAD implantation. A 6-minute walk test will be performed before the exercise session to help calculate and set the suitable intensity of exercise. Blood will be sampled pre and post exercise at each time point. Patients will perform the exercise either in the gym as part of standard post VAD exercise therapy, or in the usual VAD exercise class if the patient is an outpatient. The exercise session will be standardised, and the patient will receive 30 minutes exercise (treadmill or cycling on a stationary ergometer), at a moderate intensity of 11-13 on the Borg scale (6-20 scale).

Sponsors

Griffith University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

For LVAD patient group • Adult patient >18 years who received a LVAD • Consent obtained from patient • The patients need to be medically stable, and be able to tolerate minimum 30 minutes of exercise at moderate intensity For heart transplant patient group (Control Group A) • Adult patient >18 years who underwent heart transplant (previously requiring a VAD) • Consent obtained from patient • The patients need to be medically stable, and be able to tolerate minimum 30 minutes of exercise at moderate intensity For healthy volunteer group (Control Group B) • Adult patient >18 years are healthy volunteers • Consent obtained from healthy volunteers

Exclusion criteria

• Haematological malignancy • Pregnant • Cardiovascular or orthopaedic conditions preventing exercise therapy (such as cardiovascular instability, bone fractures etc.)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026