NCT07133672

Brief Summary

Thoracic surgery is the primary intervention used in the treatment of diseases affecting the lungs, pleura, chest wall, and mediastinum. Postoperative changes occur in both lung functions and clinical symptoms due to the procedure itself and patient-related factors. After thoracic surgery, patients often experience reduced exercise tolerance and impaired respiratory functions, negatively affecting their participation in daily activities, functional levels, and quality of life. In open thoracotomies, the incision site, severed muscles, and the size of the incision can impact upper extremity and trunk functions. The aim of this study is to investigate the effects of physiotherapy applied through digital methods on respiratory functions, respiratory muscle strength, functional capacity, upper extremity muscle strength, and quality of life in patients who have undergone thoracic surgery.

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
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

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

July 9, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

August 30, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

July 9, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

PhysiotherapyThoracic surgeryExercises

Outcome Measures

Primary Outcomes (8)

  • Forced vital capacity (FVC)

    The volume of air exhaled during a full and strongest exhalation possible after a full inspiration, as measured by a spirometry device.

    12 weeks

  • Forced expiratory volume in 1 second (FEV1)

    FEV1 is the expiratory volume in the first second of the FVC maneuver.

    12 weeks

  • Tiffeneau ratio (FEV1/FVC)

    The FEV1/FVC represents the fraction of air a patient exhales in the first second. This measurement is crucial for detecting airflow obstruction.

    12 weeks

  • Peak expiratory flow (PEF)

    Peak Expiratory Flow (PEF) is defined as a maximal expiratory flow generated during a simple maneuver using a peak flow meter via a mouthpiece.

    12 weeks

  • Respiratory Muscle Strength

    Maximum inspiratory and expiratory pressures are measured using an intraoral pressure measuring device.

    12 weeks

  • Functional Capacity

    Six-Minute Walking Test Distance measurement (in meter).

    12 weeks

  • Upper Extremity Peripheral Muscle Strength

    Measurement of shoulder flexion and abduction muscle strength using an electronic hand dynamometer.

    12 weeks

  • Health Related Quality of Life

    Saint George Respiratory Questionnaire Results. Scores range from 1 to 100. Higher scores mean worse health.

    12 weeks

Secondary Outcomes (5)

  • Shoulder Joint Range of Motion Measurement

    12 weeks

  • Trunk Lateral Flexion Flexibility

    12 weeks

  • Chest Expansion

    12 weeks

  • Shoulder Pain

    12 weeks

  • Sleep

    12 weeks

Study Arms (2)

Training group

ACTIVE COMPARATOR

During the initial face-to-face assessment session, patients will be provided with general information regarding key points to consider following thoracic surgery. Instruction on the proper techniques for performing breathing exercises will also be given. The exercise training sessions will be structured to include approximately 10 minutes of warm-up, around 30 minutes of goal-oriented exercises, and a final 10-minute cool-down period, resulting in a total average duration of 50 minutes per session.

Other: Exercise

Control group

ACTIVE COMPARATOR

During the initial face-to-face assessment session, patients will be provided with general information regarding key points to consider following thoracic surgery.

Other: Standard care

Interventions

Exercise sessions will begin with flexibility exercises targeting the shoulder and neck regions. This will be followed by breathing exercises utilizing fundamental respiratory techniques. Extremity exercises will include movements focused on the upper extremities and trunk, with progression applied according to a pre-established plan. Each session will conclude with cool-down exercises. Additionally, patients will be encouraged to engage in regular walking on a weekly basis.

Training group

Patients will receive education regarding the critical aspects to consider after hospital discharge. Standard postoperative care protocols will be implemented.

Control group

Eligibility Criteria

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

You may qualify if:

  • Patients who underwent open thoracotomy
  • Agreement to participate in the study
  • Being between the ages of 18-75
  • Having an internet connection at home and being able to participate in video-conference sessions via desktop-laptop computers, smartphones, electronic tablets, etc.

You may not qualify if:

  • Pneumonectomy surgeries
  • Having a cardiac, orthopedic, neurological or systemic disease that would prevent exercise
  • Having mental, communication or behavioral disorders that would cause problems in understanding commands and questions or performing exercises.
  • Participating in a pulmonary rehabilitation program before surgery
  • Having been hospitalized for any pulmonary disease during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseStandard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

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
Physiotherapist

Study Record Dates

First Submitted

July 9, 2025

First Posted

August 21, 2025

Study Start

August 30, 2025

Primary Completion

November 30, 2025

Study Completion

December 10, 2025

Last Updated

August 21, 2025

Record last verified: 2025-08