NCT05703022

Brief Summary

A prospective, interventional, single-group, single centre study to evaluate the feasibility of early aerobic exercise training in patients following heart valve surgery for infective endocarditis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

October 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

October 12, 2021

Last Update Submit

March 31, 2025

Conditions

EndocarditisHeart Valve Diseases

Keywords

TrainingHeart valve surgeryInfective endocarditic

Outcome Measures

Primary Outcomes (3)

  • Feasibility of inhospital aerobic interval training

    Number of completely finished training sessions will be record.

    3 months

  • Experience with inhospital aerobic inetrval training assessed by semi structured interviews

    Semi structured interviews will involve patients opinions on the strengths and weaknesses of the inhospital training intervention.

    Before discharge

  • Experience with inhospital aerobic inetrval training assessed by semi structured interviews

    Semi structured interviews will involve patients experiences of adopting and following the trainings program at home.

    3 months

Secondary Outcomes (18)

  • Intervention related endpoints 1

    During intervention

  • Intervention related endpoints 2

    During intervention

  • Intervention related endpoints 3

    During intervention

  • Intervention related endpoints 4

    During intervention

  • Patient related endpoints 1

    During intervention

  • +13 more secondary outcomes

Other Outcomes (3)

  • HeartQOL

    Changes from baseline in heart /health-related quality of life at 3 months

  • EQ5D-5L

    Changes from baseline in health-related quality of life at 3 months

  • New cardiovascular or cerebrovascular incidents.

    3 months

Study Arms (1)

Early exercise training

EXPERIMENTAL

Supervised aerobic interval training (uphill treadmill walking or cycling on an exercise bike 4x4 min at 65-85% of peak heart rate) 3 times weekly.

Other: Aerobic interval training

Interventions

Aerobic interval trainingOTHER

The intervention will start between 7 and 21 days after heart valve surgery. While hospitalized the participants will perform supervised aerobic interval training comprised 4x4 minute, 3 times per week. Intensity will start at 60% of maximum heart rate in the first week, around 13-14 in Borg RPE-Scale. The workload will be gradually increased as the participant tolerance improves, but not above 85% of maximum heart rate or 16-17 in Borg RPE Scale.

Early exercise training

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1)patients presenting with confirmed infectious endocarditis, with left-sided heart valve surgery and without arterial embolus,
  • (2)being residents of Northern Norway,
  • (3)willing and able to give informed consent 4-21 days after the heart valve surgery.

You may not qualify if:

  • (1)patients who are hemodynamically or respiratory unstable, have temperature \> 38 or positive blood cultures
  • (2)clinically significant serious concurrents medical condition such as premorbid illnesses and other concurrens serious infection which could affect the safety or tolerability of the intervention
  • (3)clinically significant concurrens musculoskeletal disorder or other concurrent disease or injury that may inhibit physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Norway

Location

MeSH Terms

Conditions

EndocarditisHeart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Gyrd Thrane, PhD

    UiT The Arctic University of Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single centre feasibility study to assess acceptability, compliance, delivery of the intervention and expected effect sizes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

January 27, 2023

Study Start

November 30, 2021

Primary Completion

October 31, 2023

Study Completion

March 27, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)