NCT06551714

Brief Summary

In this study, researchers aimed to investigate effects of neurophysiological facilitation on functional capacity and respiratory parameters of patients who underwent open heart surgery. Do neurophysiological facilitation techniques improve individuals' respiratory parameters more than phase 1 cardiac rehabilitation? Do neurophysiological facilitation techniques improve individuals' functional capacity more than phase 1 cardiac rehabilitation? Researchers will apply phase 1 cardiac rehabilitation to both groups to see the effectiveness of neurophysiological facilitation techniques.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

February 19, 2024

Last Update Submit

August 9, 2024

Conditions

Keywords

Neurophysiological facilitation techniqueCardiac rehabilitation

Outcome Measures

Primary Outcomes (11)

  • İnspiratory muscle strength

    Maximum Inspiratory Pressure (MIP) - pressure

    Before and after treatment on each day of treatment, up to 3 month

  • Expiratory muscle strength

    Maximum Expiratory Pressure (MEP) - pressure

    After and before treatment on each day of treatment, up to 3 month

  • 2 Minute Walk Test

    It is walking as fast as the person can for 2 minutes without any assistance, at a safe distance of 30 meters. - meter

    Before treatment on the first day of treatment and after treatment on the last day of treatment, up to 3 month

  • Time Up and Go (TUG)

    The person gets up from the chair, walks 3 meters, comes back and sits on the chair. - minute

    first day of treatment before treatment and last day of treatment after treatment, up to 3 month

  • Vital sign

    Oxygen saturation

    Before and after treatment on each day of treatment, up to 3 month

  • Respiratory frequency

    Number of times a person inhales and exhales in 1 minute. - number

    Before and after treatment on each day, up to 3 month

  • Blood pressure

    Blood pressure is the pressure of blood within the arteries of the circulatory system. - pressure

    Before and after treatment on day of treatment, up to 3 month

  • Heart rate

    Number of times a person heart rate in 1 minute. - number

    Before and after treatment on each day of treatment, up to 3 month

  • Life quality

    The Minnesota Living with Heart Failure Questionnaire

    Before treatment on the first day of treatment and after treatment on the last day of treatment, up to 3 month

  • Depression

    Beck's depression inventory

    Before treatment on the first day of treatment and after treatment on last day of treatment, up to 3 month

  • Symptom

    Dyspnea

    Before and after treatment on each day of treatment, up to 3 month

Study Arms (2)

Control Group

EXPERIMENTAL

Phase 1 cardiac rehabilitation

Procedure: Phase 1 cardiac rehabilitation

Study Group

ACTIVE COMPARATOR

Neurophysiological facilitation techniques in addition to phase 1 cardiac rehabilitation techniques

Procedure: Phase 1 cardiac rehabilitationProcedure: Neurophysiological facilitation techniques

Interventions

Day 1:Patients were informed about the surgery, positioning and mobilization.Range of motion (ROM), respiratory control, diaphragmatic breathing, pursed lip breathing, thoracal expansion exercises, assisted coughing,forced expiration techniques, which are the components of active breathing techniques cycle (ABTC), were taught.The use of incentive spirometry (IS) was demonstrated.Patients were performed 10 repetitions of IS exercises, and 5 repetitions ABTC and were asked to repeat them every hour.The patient was made to sit for 10 minutes and was walked 60 meters twice a day. 2:ROM, IS and diaphragmatic breathing exercises were applied 10 times each.ABTC was repeated in 5 sets. 120 meters was walked 5 times during the day. 3:Sitting time was increased to 30 minutes and walking distance was increased to 240 meters.5 steps were climbed. 4:Walking distance was increased to 360 meters.One flight of stairs was climbed.Discharge training was given.

Control GroupStudy Group

In addition to the phase 1 cardiac rehabilitation program for the group receiving neurophysiological facilitation (NPF) techniques: NPF techniques such as perioral stimulation, intercostal tension, anterior basal lift, vertebral pressure, moderate manual pressure and abdominal co-contraction were applied for ten times for ten seconds. Diaphragm facilitation exercise was performed by inhaling against resistance and holding the breath against resistance for 5 seconds. Unilateral and bilateral upper extremity proprioceptive neuromuscular facilitation (PNF) movements combined with breathing were performed. NPF techniques were performed 10 times each day throughout the treatment, while other applications (diaphragm facilitation, combined breathing exercise with upper extremity PNF technique and respiratory facilitation) were performed 5 times on the first day and 10 times on the other three days.

Study Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having open heart surgery for the first time,
  • Being between the ages of 18-75,
  • Being fully cooperative

You may not qualify if:

  • Having facial, sternum and rib fractures,
  • Having chronic renal failure,
  • Development of cerebrovascular accident,
  • Having cognitive dysfunction,
  • Development of deep vein thrombosis in the post-operative period,
  • Having neuromuscular disease,
  • Having an orthopedic disability,
  • Intubation time longer than 24 hours,
  • Staying in intensive care for more than 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim Akay Hospital

Ankara, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Yasemin Cirak, Prof. Dr.

    Istinye University

    PRINCIPAL INVESTIGATOR
  • Feyza merakli

    Istinye University

    STUDY DIRECTOR

Central Study Contacts

Feyza merakli

CONTACT

Gungor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

February 19, 2024

First Posted

August 13, 2024

Study Start

January 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

The study protocol, Informed Consent Form, Statistical Analysis Plan and Clinical Study Report will be shared upon request.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will remain open for 1 year.
Access Criteria
To be a journal in Science Citation Index (SCI), Emerging Sources Citation Index (ESCI) categories

Locations