Inspiratory Muscle Pressure and Diaphragmatic Strength in Women With Long COVID-19: A Pressure Biofeedback-Guided Training Study

NCT07397130 | Completed

• 1 other identifier: 0171/KEPK-RSUPP/07/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 is an infectious disease that can cause long-term health problems even after the acute infection has resolved. Many people who have recovered from COVID-19 continue to experience breathing difficulties, fatigue, and reduced physical capacity. These ongoing problems are often related to decreased lung function and weakness of the breathing muscles, especially the diaphragm, which plays a major role in breathing. In women after COVID-19, respiratory muscle weakness may result from inflammation during infection, prolonged bed rest, and increased effort required to breathe. This can lead to reduced inspiratory strength, shortness of breath, and limitations in daily activities. Respiratory rehabilitation is therefore important to help restore breathing muscle strength and improve overall respiratory function. One rehabilitation approach is indirect diaphragmatic muscle training using pressure biofeedback. This method provides visual or tactile feedback during breathing exercises to help patients activate and strengthen the diaphragm more effectively. Pressure biofeedback has been used as part of post-COVID-19 rehabilitation in Indonesia, but its effectiveness in improving inspiratory strength and diaphragmatic function, particularly in women after COVID-19, has not been fully evaluated. The purpose of this study is to examine the relationship between improvements in maximal inspiratory pressure and improvements in diaphragmatic strength in women recovering from COVID-19 who perform indirect diaphragmatic muscle training using pressure biofeedback. The study hypothesizes that indirect diaphragmatic training guided by pressure biofeedback can improve diaphragmatic strength and increase maximal inspiratory pressure in women after COVID-19.

Conditions

Long COVID-19 Syndrome; Post COVID-19 Syndrome; Post COVID Syndrome Long Covid

Keywords

Post Covid; Diaphragmatic Strength; Inspiratory Pressure; Pressure Biofeedback Exercise; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Diaphragmatic Muscle Strength

  Diaphragmatic muscle strength is assessed using ultrasonographic evaluation of diaphragmatic movement and thickness during respiration to determine diaphragmatic function.

  Baseline and after completion of the intervention period (at 4 weeks)

• Maximal Inspiratory Pressure (MIP)

  Maximal inspiratory pressure is measured to assess inspiratory muscle strength. MIP is evaluated using a pressure manometer during a maximal inspiratory effort and reflects the functional strength of the diaphragm and other inspiratory muscles.

  Baseline and after completion of the intervention period (at 4 weeks)

• Maximal Expiratory Pressure (MEP)

  Maximal expiratory pressure is measured to assess expiratory muscle strength. MEP is evaluated using a pressure manometer during a maximal expiratory effort and reflects the strength of the abdominal and expiratory respiratory muscles.

  Baseline and after completion of the intervention period (at 4 weeks)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group receive indirect diaphragmatic muscle training using pressure biofeedback as part of post-COVID-19 respiratory rehabilitation. The training is performed using a pressure biofeedback unit placed at the lumbosacral region to provide real-time feedback during diaphragmatic breathing exercises. Participants are instructed to perform controlled diaphragmatic breathing aimed at increasing abdominal expansion while minimizing chest wall movement. The exercise program is conducted according to a structured protocol over the intervention period to improve diaphragmatic muscle activation, increase inspiratory muscle strength, and enhance maximal inspiratory pressure.

Device: Pressure Biofeedback Unit

Control Group

NO INTERVENTION

Participants receive standard post-COVID-19 care without indirect diaphragmatic muscle training using pressure biofeedback. No structured pressure biofeedback-guided diaphragmatic training is provided during the study period.

Interventions

Pressure Biofeedback Unit DEVICE

Diaphragmatic muscle training using a pressure biofeedback unit is provided as part of post-COVID-19 respiratory rehabilitation. The pressure biofeedback unit is placed at the lumbosacral region to provide real-time feedback during diaphragmatic breathing exercises. Participants are instructed to perform controlled diaphragmatic breathing aimed at enhancing diaphragmatic activation and increasing inspiratory muscle strength.

Intervention Group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients treated at Persahabatan Hospital.
• History of COVID-19 infection.
• Attending the Pulmonology Clinic and/or the Medical Rehabilitation Clinic at Persahabatan Hospital.
• Willing to participate in indirect diaphragmatic training using pressure biofeedback for four consecutive weeks.
• Willing to participate as research subjects.

You may not qualify if:

• Female patients not treated at Persahabatan Hospital
• No history of COVID-19 infection
• Not participating in indirect diaphragmatic training using pressure biofeedback for four consecutive weeks
• Presence of other pulmonary disease such as tuberculosis, chronic obstructive pulmonary disease, or asthma

Sponsors & Collaborators

• RSUP Persahabatan: lead

Study Sites (1)

Rumah Sakit Umum Pusat Persahabatan

Jakarta, DKI Jakarta, 13230, Indonesia

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control Group (Standard rehabilitation) and Intervention Group (Pressure biofeedback exercise)

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 9, 2026
• Study Start: July 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 4 weeks
• Access Criteria: by request to my email: sitichandraw@gmail.com

Locations

ID (1)