NCT05172102

Brief Summary

Gaining a greater understanding of how the breathing exercise combined with aerobic and strengthening exercises will affects lung function and quality of life in post covid-19 persons

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable covid19

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

December 20, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

December 25, 2021

Last Update Submit

April 2, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Health-related quality of life, Medical Outcomes Study short-form (SF-36)

    assessed using the Short Form-36 (SF-36). The SF-36 scale had 8 dimensions, and each dimension was converted into a percentage score.

    at baseline

  • Health-related quality of life, Medical Outcomes Study short-form (SF-36)

    assessed using the Short Form-36 (SF-36). The SF-36 scale had 8 dimensions, and each dimension was converted into a percentage score.

    after 6 weeks

  • Respiratory function measurement

    assessed by a spirometer. The following parameters related to respiratory function will be measured: (1) forced expiratory volume in 1 second (FEV1); (2) forced vital capacity (FVC).

    at baseline

  • Respiratory function measurement

    assessed by a spirometer. The following parameters related to respiratory function will be measured: (1) forced expiratory volume in 1 second (FEV1); (2) forced vital capacity (FVC).

    after 6 weeks

Secondary Outcomes (4)

  • Chest expansion measurement

    at baseline

  • Chest expansion measurement

    after 6 weeks

  • Exercise endurance measurement

    at baseline

  • Exercise endurance measurement

    after 6 weeks

Study Arms (2)

study group

EXPERIMENTAL

Will receive diaphragmatic breathing with pursed lips as (breathing exercise), They will instruct to perform 3 different conditions will be registered: (1) 6 min of quiet breathing (3 sets of 2 min each), defined as spontaneous breathing pattern; (2) 6 min of diaphragmatic breathing (3 sets of 2 min each); and (3) 6 min of diaphragmatic breathing plus pursed-lips breathing (3 sets of 2 min each). For aerobic exercises: Will include the following exercises: walking, cycling, running and intermittent running. The exercises will perform for 18-60 minutes for 1-2 sets per week. For resistance exercises: Will include the following 8 exercises: shoulder press, biceps curl, triceps curl, bench press, leg squats, leg press, leg curl and toe raise. The exercises will perform for 60 minutes for 2-3 sets per week.

Other: breathing exercise, Aerobic exercises

control group

NO INTERVENTION

not receiving any exercises

Interventions

6 min of quiet breathing (3 sets of 2 min each), 6 min of diaphragmatic breathing (3 sets of 2 min each), 6 min of diaphragmatic breathing plus pursed-lips breathing (3 sets of 2 min each).

Also known as: resistance exercises
study group

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female. Age from 20 to 30 years old. - Body mass index (BMI) 19 to 24 kg/m2.- Non-smoker- Recovered from COVID-19 over the past 12 months. - They are experiencing mild to moderate symptoms without any complications. -
  • Able to use online communication programs.

You may not qualify if:

  • \- Anyone who does regular physical exercise.
  • history of acute illness, asthma, pulmonary fibrosis, hypertension, diabetes disease.
  • hypoxemia in rest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of medical rehabilitation

Buraidah, Al-Qassim Region, 2100, Saudi Arabia

Location

Related Publications (3)

  • Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1.

  • Mendes LP, Moraes KS, Hoffman M, Vieira DS, Ribeiro-Samora GA, Lage SM, Britto RR, Parreira VF. Effects of Diaphragmatic Breathing With and Without Pursed-Lips Breathing in Subjects With COPD. Respir Care. 2019 Feb;64(2):136-144. doi: 10.4187/respcare.06319. Epub 2018 Aug 28.

  • Ubolnuar N, Tantisuwat A, Thaveeratitham P, Lertmaharit S, Kruapanich C, Mathiyakom W. Effects of Breathing Exercises in Patients With Chronic Obstructive Pulmonary Disease: Systematic Review and Meta-Analysis. Ann Rehabil Med. 2019 Aug;43(4):509-523. doi: 10.5535/arm.2019.43.4.509. Epub 2019 Aug 31.

MeSH Terms

Conditions

COVID-19

Interventions

Breathing ExercisesExercise

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sahar Mahmoud, PhD

    Qassim University

    STUDY DIRECTOR

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor of physical therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist

Study Record Dates

First Submitted

December 25, 2021

First Posted

December 29, 2021

Study Start

December 20, 2021

Primary Completion

March 20, 2023

Study Completion

March 30, 2023

Last Updated

April 4, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study is available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations