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Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ICRS
TAET
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring cardiopulmonary exercise, cardiorespiratory fitness, aerobic training

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • WanFang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intelligent cardiopulmonary rehabilitation system (ICRS)

Traditional aerobic exercise training (TAET)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2021
Last Updated
July 16, 2022
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04833400
Brief Title
Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke
Official Title
Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
cardiopulmonary exercise, cardiorespiratory fitness, aerobic training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intelligent cardiopulmonary rehabilitation system (ICRS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional aerobic exercise training (TAET)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ICRS
Intervention Description
Patients undergo 30-minute aerobic training with ICRS, 3 sessions a week, for 4 weeks.
Intervention Type
Device
Intervention Name(s)
TAET
Intervention Description
Patients undergo 30-minute aerobic training with TAET, 3 sessions a week, for 4 weeks.
Primary Outcome Measure Information:
Title
relative VO2-peak (mL/kg/min)
Description
oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
6-min walk test
Description
The 6-minute walk test measures the distance covered while walking at a tolerable pace for 6 minutes.
Time Frame
4 weeks
Title
absolute VO2-peak (mL/min)
Description
oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
Time Frame
4 weeks
Title
workload-peak (Watt)
Description
The peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
WanFang Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen-Nung Lin, MD, MS
Phone
0970746879
Email
semitune@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

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