NCT07007507

Brief Summary

Stroke is a common cause of functional impairment and a disease that requires large financial resources and days of care(1). For a few years now, group or individual cardiorespiratory training has been a recommended part of subacute rehabilitation after stroke(2). The training form should be a routine part of stroke rehabilitation and should be able to be carried out in both hospitals, municipal facilities and at home(2). The benefits include better walking ability and improved quality of life(3). Despite the possible benefits of cardiorespiratory training, access to the training form has been limited and compliance with the recommendations has been low(4). The Rehab East Neuro Unit has decided to implement the training form in the spring of 2024 to increase access to the training form after stroke. The purpose of this pilot study is to study attendance at training sessions and adherence with the training form's recommendations and guidelines over a six-month period. By identifying any challenges that may arise during the study with recruitment, retention of participants or data collection, the pilot study will form the basis for a larger study that will involve multiple study sites. The pilot study will, through study protocols and interviews or surveys of patients and staff, shed light on study design, instruments for data collection and analysis methods. The results will be used to ensure that further studies are effective, appropriate and feasible. Compliance with guidelines will be evaluated with an exercise diary or digital registration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable stroke

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

November 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 28, 2025

Last Update Submit

June 4, 2025

Conditions

Keywords

Stroke, Aerobic exercise, Attendence, Adherence

Outcome Measures

Primary Outcomes (1)

  • Attendence

    Participation in number of organized training sessions and own physical activities

    From enrollment to the end of treatment after 8 weeks

Secondary Outcomes (1)

  • Adherence

    From enrollment to the end of treatment after 8 weeks

Study Arms (1)

Aerobic Exercise

EXPERIMENTAL

Two organized training sessions per week and one personal fitness activity once a week

Behavioral: Aerobic Exercise

Interventions

Aerobic exercise is performed by repeating sequences of light to moderate intensity activities for extended periods of time.(12) The American Heart Association recommends that for stroke survivors, exercise intensity should be 40%-70% of VO2 reserve or heart rate (HR) reserve; 55%-80% HR max; RPE 11-14 Borg rating of perceived exertion (RPE) scale 6-20 scale, 3-5 days/week, 30-60 min/session (or multiple 10 min sessions)

Aerobic Exercise

Eligibility Criteria

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

You may qualify if:

  • All stroke patients who can walk 5 meters and can sit on an ergometer cycle are invited.- Study participants must be able to read and understand the Swedish language in order to be able to assimilate study information.

You may not qualify if:

  • Patients with medical or orthopedic conditions that prevent exercise should not participate in the study.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrinnevisjukhuset

Norrköping, Östergötland County, 60182, Sweden

Location

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Klas Sandberg, PhD

    Ostergotland CC

    PRINCIPAL INVESTIGATOR
  • Klas Sandberg, PhD

    Ostergotland CC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. PT

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 5, 2025

Study Start

November 13, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 5, 2025

Record last verified: 2025-05

Locations