Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

NCT04833400 | Unknown DMC

• 1 other identifier: N202010012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

cardiopulmonary exercise; cardiorespiratory fitness; aerobic training

Outcome Measures

Primary Outcomes (1)

• relative VO2-peak (mL/kg/min)

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

  4 weeks

Secondary Outcomes (3)

• 6-min walk test

  4 weeks

• absolute VO2-peak (mL/min)

  4 weeks

• workload-peak (Watt)

  4 weeks

Study Arms (2)

Intelligent cardiopulmonary rehabilitation system (ICRS)

EXPERIMENTAL

The ICRS is very likely to the conventional stationary biking, but with an algorithm that automatically controls the resistance of pedalling, considering the instant heart rate and cadence, to keep the heart rate within the targeted heart rate zone.

Device: ICRS

Traditional aerobic exercise training (TAET)

ACTIVE COMPARATOR

The TAET is performed with stationary biking, with intensity being set as subjective rating of perceived exertion at a "somewhat hard" to "hard" level. The resistance of pedaling is ad-justed by the user or physical therapist.

Device: TAET

Interventions

ICRS DEVICE

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

Intelligent cardiopulmonary rehabilitation system (ICRS)

TAET DEVICE

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

Traditional aerobic exercise training (TAET)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

WanFang Hospital

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: April 6, 2021
• Study Start: January 25, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)