Effects of HAL therapy in patients with chronic heart failure

JRCT ID: jRCTs032180105

Registered date:04/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: A patient with chronic heart failure
• Date of first enrollment: 06/03/2018
• Target sample size: 60
• Study type: Interventional
• Intervention(s): In the HAL group, exercise therapy with HAL for 5 to 30 minutes is performed once a day, and 6 to 10 times during the study period. In the control group, exercise therapy without HAL is carried out similarly as the HAL group.

Outcome(s)

Primary Outcome

Heart rate, blood pressure, and ratings of subjective exercise intensity (Borg scale) during exercise.
The number of days needed for independent walking from the start of exercise therapy in patients who can self-walk at the time of discharge from the hospital. It is possible to walk at a distance of 40 to 50 m without assistance (monitoring or independent walking).
Number of days from start of exercise therapy to discharge.
Adverse effects.
Prognosis in 1 year after discharge.
Occurrence of death (rate) or survival (rate) (duration).
Re-hospitalization rate or re-hospital avoidance rate (duration).
Cardiac accident incidence rate or avoidance rate (term).

Secondary Outcome

Body composition (impedance method)
Severity assessment of heart failure (NYHA classification)
Blood test (BNP)
Physiological cost index
Double product
Grip strength
Thigh muscle thickness
Isometric knee extensor strength
Standing ability (30-seconds chair-stand test)
10 m walking speed
6 min walking distance
SPPB (Short Physical Performance Battery)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who satisfy all the following criteria are targeted.
1. A patient who meets health insurance standards of current cardiac rehabilitation (Left ventricular ejection fraction is 40 % or less, brain natriuretic peptide (BNP) is 80 pg / mL or more, peak oxygen uptake obtained from cardiopulmonary exercise test is 80 % or less of normal value) who performed exercise therapy at the University of Tsukuba Hospital.
2. A patient who can consent document by himself/herself.
3. A patient aged 20 years or older at consent acquisition.
4. A patient whose height is approximately within 150-190 cm, whose weight is approximately within 40-100 kg, and who can wearing HAL.
5. A patient who can continue hospitalization during the clinical study.

Exclude criteria

Patients who conflict with one of the following criteria are excluded and not subject to this clinical study.
1. A patient who corresponds to contraindications of exercise, such as decompensated heart failure, unstable angina, symptomatic aortic valve stenosis, symptomatic hypertropic obstructive cardiomyopathy, exercise-induced arrhythmia, acute myocarditis, or systemic inflammatory disease.
2. A patient who is not able to attend this study due to orthopedic, central/peripheral nervous-system, or social problem.
3. A patient with bleeding tendencies or complications such as osteoporosis / fracture which are problematic in exercise.
4. A patient who cannot be put on the electrode on the skin surface due to a skin disease etc.
5. A patient whose informed consent cannot be obtained because of disturbance of his/her consciousness, or cognition disorder.
6. A patient who is anticipated to be unable to complete the clinical study by the principal investigator or member doctors of the study.
7. A patient who is judged to be medically unstable by the principal investigator or member doctors after comprehensively considering physical findings, blood test findings, etc.

Related Information

• Primary Sponsor: Koike Akira
• Source(s) of Monetary Support: Grant-in-Aid for Scientific Research (C)
• Secondary ID(s): UMIN000030761