NCT03558542

Brief Summary

This study is aimed to determine the effects of an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program on the quality of life, care-giver burden and overall well-being of the patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

May 14, 2018

Last Update Submit

June 14, 2018

Conditions

StrokeHemiplegia

Outcome Measures

Primary Outcomes (1)

  • VO2max

    Maximum oxygen consumption

    2 months

Study Arms (1)

Study Group

EXPERIMENTAL

cardiopulmonary rehabilitation plus neurorehabilitation

Other: cardiopulmonary rehabilitation plus neurorehabilitation

Interventions

cardiopulmonary rehabilitation plus neurorehabilitationOTHER

Patients with stroke will undergo an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program

Study Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A history of ischemic stroke at least 6 months ago

You may not qualify if:

  • any cardiac or pulmonary problem that renders the patient unavailable for the program
  • mental impairment
  • not being able to perform exercise testing
  • not being able to walk independently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Neurological Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 15, 2018

Study Start

June 1, 2018

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

June 15, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share