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Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke: a Feasibility Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04833400
Enrollment
40
Registered
2021-04-06
Start date
2022-01-25
Completion date
2023-08-01
Last updated
2022-07-20

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

Conditions

Stroke

Keywords

cardiopulmonary exercise, cardiorespiratory fitness, aerobic training

Brief summary

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.

Detailed description

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.

Interventions

DEVICETAET

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

DEVICEICRS

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

Sponsors

Taipei Medical University WanFang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
relative VO2-peak (mL/kg/min)4 weeksoxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.

Secondary

MeasureTime frameDescription
6-min walk test4 weeksThe 6-minute walk test measures the distance covered while walking at a tolerable pace for 6 minutes.
absolute VO2-peak (mL/min)4 weeksoxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
workload-peak (Watt)4 weeksThe peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026