NCT02717715

Brief Summary

This study aims to determine the effect of a supervised home-based physical fitness program on the aerobic capacity, quality of gait and health related quality of life in people with chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term lifestyle change will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

March 5, 2016

Last Update Submit

July 18, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in peak oxygen uptake

    4 weeks, 8 weeks and 5 months after start of rehabilitation

Study Arms (2)

Intervention group

EXPERIMENTAL

Stroke patients from the intervention group will be, on top of usual care, offered a holistic home based and semi-supervised stroke rehabilitation program followed by a period of tele-supervision.

Behavioral: Home base stroke rehabilitation

Control group

NO INTERVENTION

The participants in the control group will only receive usual care.

Interventions

Home base stroke rehabilitationBEHAVIORAL

The intervention consists of physiotherapy exercises targeting functional and physical capacity.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ability to give informed consent
  • ability to understand measurement procedures defined as MMSE \>24
  • last stroke \>6 months ago
  • mild to moderate stroke deficit defined by Fugl Meyer test score of 27 to 90 for upper and lower extremities
  • FAC ≥3
  • medical clearance to participate in a moderate exercise program
  • living at home and having a minimum of 5 stairs at home

You may not qualify if:

  • serious cardiac condition
  • other serious end organ damage
  • other neurological deficits leading to disability
  • uncontrolled blood pressure (systolic pressure \>140, diastolic pressure \>90)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anton De Kom University

Paramaribo, Suriname

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 5, 2016

First Posted

March 24, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

SU(1)