Efficacy of Cardiac Rehabilitation with Assistance from Hybrid Assistive Limb in Patients with Chronic Heart Failure: Protocol for a Randomized Controlled Study.

The hybrid assistive limb (HAL) provides motion assistance based on bioelectrical signals detected on the skin surface when muscle forces are generated. The lumbar-type HAL is expected to expand the therapeutic options for severe cardiac patients who have difficulty in moving on their own legs. We aim to compare the efficacy of exercise therapy performed with assistance from a lumbar-type HAL versus conventional training (sit-to-stand exercise without HAL) in patients with chronic heart failure. This investigation will be a randomized, nonblinded, controlled study. Sixty patients who satisfy the criteria to receive cardiac rehabilitation therapy under the Japanese national insurance system will be enrolled at the University of Tsukuba Hospital. Participants randomly assigned to 2 groups (HAL group and conventional group) at a 1:1 allocation ratio will perform exercise therapy either with HAL or without HAL for 5-30 min once a day for 6-10 days. Outcome parameters will be measured just before and after the completion of the exercise therapy and at 1 year after hospital discharge. The primary outcomes will be the heart rate, blood pressure, subjective ratings of exercise intensity during exercise (Borg scale), number of days from the start of exercise therapy to independent walking and to discharge, and prognosis (mortality and cardiovascular events) over the 1-year period after discharge. The secondary outcomes will be the assessment of heart failure severity, brain natriuretic peptide, grip strength, thigh muscle thickness, isometric knee extensor strength, standing ability, 10-meter walking speed, 6-min walking distance, short physical performance battery, and adverse events. Unpaired t tests will be used for baseline assessments and outcome measures. This is the first randomized controlled study to examine the efficacy and feasibility of lumbar-type HAL in patients with chronic heart failure. If the results confirm beneficial effects in the outcomes of patients with heart failure, this study will add more evidence in support of the use of the lumbar-type HAL as an effective tool in new cardiac rehabilitation programs.