Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

Taipei Medical University WanFang Hospital40 enrolled

Overview

By comparing with traditional aerobic exercise training (TAET), we investigate the effects of an intelligent cardiopulmonary rehabilitative system (ICRS) on cardiopulmonary fitness and patient satification among patients with chronic stroke.

Cycle ergometer training is one of the common indoor aerobic exercises for enhancing cardiorespiratory fitness in patients after stroke. However, studies had suggested that patients may be undertrained for reasons such as a tight time schedule for other rehabilitation programs and lack of objective evaluation on the training intensity. To address the issue of inadequate cycle ergometer training in poststroke patients, in this study, an intelligent cardiopulmonary rehabilitation system was developed and incorporated into a bicycle ergometer, allowing dynamically auto-adjust paddling resistance considering the instant heart rate and cadence, with a goal to maintain the hear rate within the pre-determined heart rate zone. The purpose of the current study is to investigate the feasibility of the ICRS in stroke patients and whether it outweighs the traditional feedback on training intensity. A single-blind crossover trial is adopted with 40 participants estimated to be recruited and randomly assigned to the group A and group B. Group A received training with ICRS while Group B received training with TAET at the beginning. The intensity of ICRS is set as 60%\~80% heart rate reserve (HRR) which is obtained from cardiopulmonary exercise testing (CPET) at pretest. The intensity of TAET is set as subjective rating of perceived exertion at "somewhat hard" to "hard" level. Both groups will receive 30 minutes of training per session, 3 sessions a week for four weeks followed by a washout period of 4-week break. Subjects are crossed-over to the alternate treatment afterwards. CPET evaluations will be conducted in a total of 4 times before and after treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

ICRSDEVICE

Patients undergo 30-minute aerobic training with ICRS, 3 sessions a week, for 4 weeks.

TAETDEVICE

Patients undergo 30-minute aerobic training with TAET, 3 sessions a week, for 4 weeks.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 20-75 y/o * Healthy people * Chronic stroke \> 6 months * Able to walk independently \> 6 minutes with or without orthosis * Able to use stationary bike * MRS(Modified Rankin Scale) ranged 1 to 3 Exclusion Criteria: * Patients whose heart rate can not be used as the indicator of training intensity (eg, ar-rhythmia, atrial fibrillation, beta-blockers users) * With any reason that the patient is not suitable to undergo aerobic training * Patients who are unable to do cycling due to musculoskeletal problems * Patients who can not follow the instruction of trainers due to cognitive or emotional-problems. * Patients whose medical condition is not unstable.

Locations (1)

WanFang Hospital

New Taipei City, Taiwan

RECRUITING

Outcomes

Primary Outcomes

relative VO2-peak (mL/kg/min)

oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.

Time frame: 4 weeks

Secondary Outcomes

6-min walk test

The 6-minute walk test measures the distance covered while walking at a tolerable pace for 6 minutes.

Time frame: 4 weeks

absolute VO2-peak (mL/min)

oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.

Time frame: 4 weeks

workload-peak (Watt)

The peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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