NCT05616858

Brief Summary

The physical and social effects of exercise programs and daily exercise have already been demonstrated in stroke. However, stroke survivors have shown a passive attitude towards the exercise program and there was little guideline and experience of the stroke exercise program in the community. Therefore, the study provides patients with an adequate guide to a complex exercise program after discharge based on the medical records.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 18, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

October 31, 2022

Last Update Submit

August 13, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Peak VO2

    Maximal VO2 from cardiopulmonary exercise test

    Baseline evaluation

  • Peak VO2

    Maximal VO2 from cardiopulmonary exercise test

    Follow-up evaluation (through study completion, an average of 6 weeks)

Secondary Outcomes (32)

  • Functional ambulation category (0-5, the higher the better)

    Baseline evaluation

  • Functional ambulation category (0-5, the higher the better)

    Follow-up evaluation (through study completion, an average of 6 weeks)

  • Berg balance scale (0-56, the higher the better)

    Baseline evaluation

  • Berg balance scale (0-56, the higher the better)

    Follow-up evaluation (through study completion, an average of 6 weeks)

  • Timed up and go

    Baseline evaluation

  • +27 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Group with exercise program

Behavioral: Complex exercise program

Control group

NO INTERVENTION

Group without exercise program

Interventions

Stretching exercise, aerobic exercise, strengthening and balancing exercise

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Community indwelling stroke patients discharged from Pusan National University Yangsan Hospital
  • Independent ambulator (FAC over 4)
  • Independent daily activities (Modified Rankin Scale less than 2)
  • No apparent spasticity on hemiplegic side (Modified Ashworth scale less than 1)
  • Hemiplegic side motor grades (Manual muscle testing, MMT) more than 3

You may not qualify if:

  • MMSE less than 18
  • BBS less than 41
  • Severe aphagia who cannot communicate
  • Severe cardiovascular conditions inhibiting exercise programs
  • Musculoskeletal problems inhibiting exercise programs
  • Other medical conditions considered by physiatrists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

MeSH Terms

Conditions

StrokeCommunication

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized, open-label, case-control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 15, 2022

Study Start

March 18, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations