Verification of training effect and safety with a balance exercise assist robot in elderly patients with chronic heart failure

JRCT ID: jRCTs042190086

Registered date:31/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Elderly patients with chronic heart failure
• Date of first enrollment: 31/03/2020
• Target sample size: 90
• Study type: Interventional
• Intervention(s): The balance exercise with a balance exercise assist robot for a total of 16 times for a period of 20 minutes once a week for 4 months for elderly chronic heart failure patient.

Outcome(s)

• Primary Outcome: TUG (Timed up and go test)

Secondary Outcome

10m gait speed
SPPB (Short physical performance battery)
One leg standing time
Muscle strength (knee extension, grip)
Muscle mass
Kihon checklist
J-CHS criteria (Japanese version Cardiovascular Health study criteria)
Exercise capacity (peak oxygen uptake; peak VO2)
LSA (Life-space assessment)
FIM (Functional independence measure)
The Lawton instrumental activities of daily living scale
FES-I (Falls efficacy scale-international)
HADS (Hospital anxiety and depression scale)
GDS (Geriatrics depression scale)

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The general condition is stable
Able to independent walking
Informed-consent has been obtained

Exclude criteria

Patients who have fatal arrhythmias that are not stable due to medical treatment
Patients with aortic valve stenosis and aortic aneurysm with motion restriction,
Uncontrolled hypertension (systolic blood pressure over 180 mmHg or diastolic blood pressure over 120 mmHg)
Hearing loss to some extent in the practice. Persons with visual impairment
People with dementia and severe higher brain dysfunction who do not understand the content of the explanation

Related Information

• Primary Sponsor: Kondo Izumi