NCT06640699

Brief Summary

The aim of the study is to investigate the effects of neurophysiological facilitation techniques, applied in addition to Phase I cardiac rehabilitation in the early postoperative period after coronary artery bypass graft (CABG) surgery, on left ventricular function, respiratory functions, and functional capacity.

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
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

October 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 9, 2024

Last Update Submit

October 11, 2024

Conditions

Keywords

coronary artery bypassrespiratory function testventricular ejection fraction

Outcome Measures

Primary Outcomes (3)

  • ecocardiography device

    ejection fraction will assess with ecocardiography.

    3 months

  • spirometer

    respiratory function test will assess with spirometer

    3 months

  • 6 Minutes walking test

    functional capacity will assess with 6 minutes walk test.

    3 months

Study Arms (2)

NFT Group

EXPERIMENTAL

NFT group will receive Phase I cardiac rehabilitation and neurophysiological facilitation techniques.

Other: exercise

Control Group

ACTIVE COMPARATOR

Control group will receive Phase I cardiac rehabilitation alone.

Other: exercise

Interventions

exercises with using neurophysiological facilitation techniques and cardiac rehabilitation.

Control GroupNFT Group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-time undergoing open-heart surgery
  • Aged between 50 and 85 years
  • Full cooperation

You may not qualify if:

  • Presence of facial, sternum, or rib fractures
  • Chronic renal failure
  • Development of cerebrovascular events
  • Cognitive function impairment
  • Development of deep vein thrombosis in the postoperative period
  • Presence of neuromuscular disease
  • Presence of orthopedic disabilities
  • Intubation duration longer than 24 hours
  • Staying in intensive care for more than 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gamze Aydın, PhD

    Okan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamze Aydın, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
participants will be blind to groups, outcomes assessor will be blind to groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

November 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share