NCT07656610

Brief Summary

This experimental study was designed to investigate the effects of respiratory muscle training and walking exercise on selected blood, respiratory, functional, dyspnea, sleep quality, and quality-of-life outcomes in women who had recovered from COVID-19-related lung inflammation/pneumonia. The study included women aged 20 to 45 years who had experienced COVID-19 with pneumonia, reported dyspnea, and had reduced quality of life. A total of 80 female participants were divided into four groups: respiratory muscle training plus walking exercise, respiratory muscle training alone, walking exercise alone, and a control group, with 20 participants in each group. Measurements were performed before and after the intervention period. The assessments included pulmonary function testing, maximal inspiratory pressure, the 6-minute walk test, the modified Borg scale for dyspnea, the Nottingham Health Profile, the Pittsburgh Sleep Quality Index, and selected blood parameters. The study aimed to determine whether respiratory muscle training, walking exercise, or their combination could improve respiratory function, inspiratory muscle strength, functional capacity, dyspnea, sleep quality, quality of life, and blood-related parameters in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 16, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 11, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

Respiratory Muscle TrainingWalking ExerciseCOVID-19DyspneaPost-COVID-19 RecoveryMaximal Inspiratory Pressure

Outcome Measures

Primary Outcomes (1)

  • Change in Maximal Inspiratory Pressure

    Change in maximal inspiratory pressure from baseline to post-intervention. Maximal inspiratory pressure was used to assess inspiratory respiratory muscle strength.

    Baseline and Week 8

Secondary Outcomes (9)

  • Change in Forced Vital Capacity

    Baseline and Week 8

  • Change in Forced Expiratory Volume in 1 Second

    Baseline and Week 8

  • Change in Peak Inspiratory Flow

    Baseline and Week 8

  • Change in Inspiratory Volume

    Baseline and Week 8

  • Change in 6-Minute Walk Test Distance

    Baseline and Week 8

  • +4 more secondary outcomes

Study Arms (4)

Respiratory Muscle Training

EXPERIMENTAL

Participants in this arm received respiratory muscle training for 8 weeks using a pressure-threshold respiratory muscle training device. The training intensity was set at 50% of each participant's maximal inspiratory pressure and was updated according to weekly changes in respiratory muscle strength.

Behavioral: Respiratory Muscle Training

Respiratory Muscle Training Plus Walking Exercise

EXPERIMENTAL

Participants in this arm received respiratory muscle training in addition to a structured walking exercise program for 8 weeks. The walking exercise was performed 3 days per week for 40 minutes at 40% intensity based on the target heart rate method, either outdoors or on a treadmill. Exercise intensity was monitored using an optical heart rate sensor.

Behavioral: Respiratory Muscle TrainingBehavioral: Walking Exercise

Walking Exercise

EXPERIMENTAL

Participants in this arm performed structured walking exercise for 8 weeks. Walking was performed 3 days per week for 40 minutes at a pace of approximately 4-6 km/hour and at 40% intensity based on the target heart rate method. Exercise intensity was monitored during the sessions using an optical heart rate sensor.

Behavioral: Walking Exercise

Control

NO INTERVENTION

Participants in this arm did not receive any structured exercise intervention and continued their usual daily routine during the study period.

Interventions

Participants performed respiratory muscle training for 8 weeks using a pressure-threshold respiratory muscle training device. The training load was set at 50% of each participant's maximal inspiratory pressure. Training was performed 5 days per week, twice daily, with 30 breaths in each session. Maximal inspiratory pressure was reassessed weekly, and the training load was adjusted according to the updated value.

Respiratory Muscle TrainingRespiratory Muscle Training Plus Walking Exercise

Participants performed a structured walking exercise program for 8 weeks. Walking exercise was performed 3 days per week for 40 minutes at an intensity corresponding to 40% based on the target heart rate method. Walking was performed either outdoors or on a treadmill at an approximate pace of 4 to 6 km/hour. Exercise intensity was monitored using a Polar Verity Sense optical heart rate sensor. Before walking, participants completed a 10-minute warm-up and stretching protocol for the upper and lower extremities.

Respiratory Muscle Training Plus Walking ExerciseWalking Exercise

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female participants aged 20 to 45 years
  • History of COVID-19-related pneumonia
  • Presence of dyspnea after COVID-19
  • Modified Borg dyspnea score between 1 and 7 after the 6-minute walk test
  • Resting oxygen saturation between 90% and 95%
  • Incomplete resolution of COVID-19-related lesions on chest radiography
  • Voluntary agreement to participate in the study
  • Signed written informed consent form

You may not qualify if:

  • Modified Borg dyspnea score between 0 and 1
  • Modified Borg dyspnea score greater than 7
  • History of chronic obstructive pulmonary disease, heart failure, or pulmonary fibrosis causing dyspnea before COVID-19 pneumonia
  • Upper abdominal or thoracic surgery within the previous 3 months
  • Cancer
  • Pregnancy
  • Presence of another disease contributing to dyspnea in addition to COVID-19-related dyspnea
  • Cardiovascular, musculoskeletal, or nervous system involvement related to COVID-19
  • Mental disorder or mental instability
  • Language barrier preventing understanding of Turkish
  • Refusal to participate or withdrawal from the study at any stage
  • History of being a competitive athlete
  • Lack of voluntary participation or refusal to sign the written informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University Çorum Erol Olçok Training and Research Hospital

Çorum, Çorum, 19100, Turkey (Türkiye)

Location

Related Publications (1)

  • Tosun MI. Investigation of the Effects of Respiratory Muscle Training and Walking Exercises on Some Blood and Respiratory Parameters in Patients Recovered From COVID-19 Lung Inflammation. Doctoral dissertation. Hitit University, Graduate School, Department of Physical Education and Sports; 2023.

    BACKGROUND

MeSH Terms

Conditions

Signs and Symptoms, RespiratoryCOVID-19Dyspnea

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The study was designed as a single-blind experimental trial. Participants were assigned to one of four groups: respiratory muscle training, respiratory muscle training plus walking exercise, walking exercise, or control. Participants were masked to the comparative study hypotheses and were not informed which intervention was expected to be superior.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to one of four parallel study groups for the duration of the 8-week intervention period: respiratory muscle training, respiratory muscle training plus walking exercise, walking exercise, or control. Each group included 20 participants, and all groups underwent pre- and post-intervention assessments.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 18, 2026

Study Start

January 16, 2023

Primary Completion

May 26, 2023

Study Completion

May 29, 2023

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly because the dataset contains personal health-related information collected from female participants who had recovered from COVID-19-related pneumonia. The data were collected as part of a doctoral thesis study and were analyzed in de-identified form for the purposes of the study.

Locations