Effectiveness of Functional Respiratory Muscle Training in Post-COVID-19 Syndrome

NCT07051954 | Recruiting

• 1 other identifier: 2024/12-16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effects of core stabilization exercises and functional inspiratory muscle training (IMT) on various physiological and psychological parameters in individuals with post-COVID-19 syndrome. Participants diagnosed with post-COVID-19 syndrome will be randomly assigned to two groups using stratified computer-assisted randomization. One group will undergo an 8-week core stabilization training, while the other will receive combined core stabilization and IMT training. Exercise training will be conducted three times a week, with each session lasting 50 minutes. Comprehensive pre- and post-intervention assessments will be conducted, including exercise capacity, respiratory and peripheral muscle strength, trunk endurance, balance, anxiety, depression, and fatigue levels. The primary outcome measures are respiratory muscle strength and trunk endurance. Participants must be aged 18-65 years, have at least a primary education level, speak Turkish, and be classified as level 2-3 on the Post-COVID-19 Functional Status Scale (PCFS). Eligible participants will be referred by the Internal Medicine Department at Hacettepe University. The study will utilize various assessment tools, including maximal inspiratory/expiratory pressure (MIP/MEP) tests, Functional Movement Screen (FMS), plank and Sorenson endurance tests, the Timed Up and Go Test for balance, handgrip and knee extension strength tests, body composition analysis, and the SF-36 quality of life questionnaire.

Conditions

Post COVID-19 Syndrome; Core Stabilization; Functional Inspiratory Muscle Training

Keywords

Post-COVID Syndrome; Trunk Muscle Endurance; Exercise Capacity; Functional Inspiratory Muscle Training (IMT); Core Stabilization

Outcome Measures

Primary Outcomes (4)

• Respiratory muscle strength

  Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) with mouth-pressure device

  Baseline and after 12 weeks of intervention.

• Plank Endurance Test

  Plank Test: Plank time is a common test to evaluate core stability. The patient is given a plank position and the maximum endurance time they can hold this position is measured.

  Baseline and after 12 weeks of intervention.

• Sorenson Endurance Test

  Sorenson Test (Extensor Endurance Test): In this test, the person lies horizontally on the end of a table and is asked to keep their body in a fixed position outside the table. The endurance time in this position is evaluated to measure core stability.

  Baseline and after 12 weeks of intervention.

• Side Bridge Endurance Test

  Side Bridge Test: It is an endurance test based on time in the side plank position. The difference between the times on the right and left sides can provide information about core stabilization.

  Baseline and after 12 weeks of intervention.

Secondary Outcomes (5)

• Health Status

  Baseline and after 12 weeks of intervention.

• Fatigue Perception

  Baseline and after 12 weeks of intervention.

• Dynamic respiratory muscle strength

  Baseline and after 12 weeks of intervention.

• Exercise motivation

  Baseline and after 12 weeks of intervention.

• Patient satisfaction and improvement

  Baseline and after 12 weeks of intervention.

Study Arms (2)

Core Stabilization Group

ACTIVE COMPARATOR

Participants will receive an 12-week core stabilization exercise program only.

Other: Core Stabilization

Functional IMT Group

EXPERIMENTAL

Participants will receive an 12-weeks core stabilization exercise program plus functional inspiratory muscle training (IMT).

Other: Core Stabilization; Other: Functional Inspiratory Muscle Training (IMT)

Interventions

Core Stabilization OTHER

12-week supervised core stabilization training, 3 sessions per week, 45 minutes per session.

Core Stabilization Group; Functional IMT Group

Functional Inspiratory Muscle Training (IMT) OTHER

IMT using a portable inspiratory muscle training device at 60% MIP, progressively increased over 12 weeks.

Functional IMT Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Post-COVID-19 Syndrome.
• Literate and able to understand study procedures.
• Aged between 18 and 65 years.
• Willing to voluntarily participate in the study.
• Classified as functional class 2-3 according to the Post-COVID-19 Functional Status Scale (PCFS).
• Clinically stable; comorbid conditions such as hypertension or diabetes must be controlled.
• No orthopedic or neurological conditions that would prevent assessment of peripheral muscle strength, balance, or exercise capacity.

You may not qualify if:

• History of recent myocardial infarction or pulmonary embolism.
• Presence of uncontrolled chronic diseases.
• Any orthopedic or neurological disorders that limit mobility.
• Neurological impairments (e.g., cerebrovascular disease) or psychiatric disorders that impair cooperation or compliance with exercise testing.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Çankaya, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• EBRU CALIK, Professor

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebru Calik, PhD

CONTACT

+905442850087; ecalik85@gmail.com

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: Professor

Model Details: The study includes two groups: one group performing core stabilization exercises and the other performing both core stabilization and functional inspiratory muscle training.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 4, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)