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Effects of Respiratory Muscle Training in Individuals With Long-term Post-COVID-19 Symptoms

Primary Purpose

Covid19, Post-acute COVID-19 Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory + expiratory muscle training group
Inspiratory + expiratory muscle training sham group
Exercise training program
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Respiratory Muscle Training, Tele-rehabilitation, Quality of Life, Exercise

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 18 years who presented long-term post-COVID-19 symptoms of fatigue and dyspnoea for at least 3 months after the COVID-19 diagnosis

Exclusion Criteria:

  • Progressive respiratory, neuromuscular or neurological disorders and/or psychiatric or cognitive conditions that hindered their ability to cooperate
  • Comorbidity that could interfere with the study interventions
  • Any contraindication to the training interventions
  • Previous inclusion in a rehabilitation program for their long-term post-COVID-19 symptoms (previous 3 months)

Sites / Locations

  • Hospital Universitario 12 de Octubre de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Exercise training + Inspiratory and expiratory muscle training group

Exercise training + Inspiratory and expiratory muscle training sham group

Arm Description

Participants will perform a cardiovascular exercise program 2 days per week during 8 weeks in the hospital, combined with an inspiratory and expiratory muscle training by a threshold device at home, twice a day, 3 days per week, for 8 weeks supervised by a physiotherapist through a virtual platform.

Participants will perform a cardiovascular exercise program 2 days per week during 8 weeks in the hospital, combined with an inspiratory and expiratory muscle training by a sham threshold device at home, twice a day, 3 days per week, for 8 weeks supervised by a physiotherapist through a virtual platform.

Outcomes

Primary Outcome Measures

Change in quality of life
Change in quality of life between baseline and post-intervention, as measured by the EuroQol-5D questionnaire which consists of 5 dimensions with 5 response options based on severity level, ranging from 1 to 5. An index score is provided, ranging from 0 (death) to 1 (full health).
Change in exercise tolerance
Change in exercise tolerance between baseline and post-intervention, as measured by a cardiopulmonary exercise test

Secondary Outcome Measures

Change in respiratory muscle function
Change in inspiratory/expiratory muscle strength and inspiratory muscle endurance between baseline and post-intervention, as measured by maximum static inspiratory and expiratory pressures and by a constant load breathing test
Change in physical function
Change in lower and upper limb strength between baseline and post-intervention, as measured by 1-min Sit-to-Stand and peripheral muscle force (dynamometry)
Change in pulmonary function
Change in pulmonary function and diffusion capacity for carbon monoxide between baseline and post-intervention, as measured by pulmonary function tests
Change in psychological status
Change in anxiety/depression levels between baseline and post-intervention, as measured by Hospital Anxiety and Depression Scale

Full Information

First Posted
October 7, 2022
Last Updated
September 27, 2023
Sponsor
Universidad Complutense de Madrid
Collaborators
Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05597774
Brief Title
Effects of Respiratory Muscle Training in Individuals With Long-term Post-COVID-19 Symptoms
Official Title
Effects of Respiratory Muscle Training Combined With an Exercise Training Program in Individuals With Long-term Post-COVID-19 Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
September 22, 2023 (Actual)
Study Completion Date
September 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main objective of the present study is to observe the short-term effects of respiratory muscle training combined with an exercise training program on quality of life and exercise tolerance in individuals with long-term post-COVID-19 symptoms. As secondary objectives, the effects on respiratory muscle function, physical and lung function, as well as on the psychological state of these individuals.
Detailed Description
It is a double-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: 1) Exercise training program + Inspiratory muscle training + Expiratory muscle training, 2) Exercise training program + Sham Inspiratory muscle training + Sham Expiratory muscle training. The exercise training program will be delivered in hospital and will be applied 2 sessions per week during 8 weeks. The exercise component will be lasted for 1hour and it consisted of cardiovascular exercises. The respiratory muscle training program will be applied twice a day, 3 sessions per week during 8 weeks by a threshold device. The evening sessions will be supervised by a physiotherapist through a virtual platform. Participants received baseline assessments at the beginning of the intervention and post-intervention assessments at the end of the 8th week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Post-acute COVID-19 Syndrome
Keywords
Respiratory Muscle Training, Tele-rehabilitation, Quality of Life, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training + Inspiratory and expiratory muscle training group
Arm Type
Experimental
Arm Description
Participants will perform a cardiovascular exercise program 2 days per week during 8 weeks in the hospital, combined with an inspiratory and expiratory muscle training by a threshold device at home, twice a day, 3 days per week, for 8 weeks supervised by a physiotherapist through a virtual platform.
Arm Title
Exercise training + Inspiratory and expiratory muscle training sham group
Arm Type
Sham Comparator
Arm Description
Participants will perform a cardiovascular exercise program 2 days per week during 8 weeks in the hospital, combined with an inspiratory and expiratory muscle training by a sham threshold device at home, twice a day, 3 days per week, for 8 weeks supervised by a physiotherapist through a virtual platform.
Intervention Type
Other
Intervention Name(s)
Inspiratory + expiratory muscle training group
Intervention Description
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
Intervention Type
Other
Intervention Name(s)
Inspiratory + expiratory muscle training sham group
Intervention Description
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
Intervention Type
Other
Intervention Name(s)
Exercise training program
Intervention Description
Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer.
Primary Outcome Measure Information:
Title
Change in quality of life
Description
Change in quality of life between baseline and post-intervention, as measured by the EuroQol-5D questionnaire which consists of 5 dimensions with 5 response options based on severity level, ranging from 1 to 5. An index score is provided, ranging from 0 (death) to 1 (full health).
Time Frame
Baseline and 1-week post-intervention (9 weeks from baseline)
Title
Change in exercise tolerance
Description
Change in exercise tolerance between baseline and post-intervention, as measured by a cardiopulmonary exercise test
Time Frame
Baseline and 1-week post-intervention (9 weeks from baseline)
Secondary Outcome Measure Information:
Title
Change in respiratory muscle function
Description
Change in inspiratory/expiratory muscle strength and inspiratory muscle endurance between baseline and post-intervention, as measured by maximum static inspiratory and expiratory pressures and by a constant load breathing test
Time Frame
Baseline and 1-week post-intervention (9 weeks from baseline)
Title
Change in physical function
Description
Change in lower and upper limb strength between baseline and post-intervention, as measured by 1-min Sit-to-Stand and peripheral muscle force (dynamometry)
Time Frame
Baseline and 1-week post-intervention (9 weeks from baseline)
Title
Change in pulmonary function
Description
Change in pulmonary function and diffusion capacity for carbon monoxide between baseline and post-intervention, as measured by pulmonary function tests
Time Frame
Baseline and 1-week post-intervention (9 weeks from baseline)
Title
Change in psychological status
Description
Change in anxiety/depression levels between baseline and post-intervention, as measured by Hospital Anxiety and Depression Scale
Time Frame
Baseline and 1-week post-intervention (9 weeks from baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years who presented long-term post-COVID-19 symptoms of fatigue and dyspnoea for at least 3 months after the COVID-19 diagnosis Exclusion Criteria: Progressive respiratory, neuromuscular or neurological disorders and/or psychiatric or cognitive conditions that hindered their ability to cooperate Comorbidity that could interfere with the study interventions Any contraindication to the training interventions Previous inclusion in a rehabilitation program for their long-term post-COVID-19 symptoms (previous 3 months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibai López de Uralde, PhD
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario 12 de Octubre de Madrid
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35236727
Citation
McNarry MA, Berg RMG, Shelley J, Hudson J, Saynor ZL, Duckers J, Lewis K, Davies GA, Mackintosh KA. Inspiratory muscle training enhances recovery post-COVID-19: a randomised controlled trial. Eur Respir J. 2022 Oct 6;60(4):2103101. doi: 10.1183/13993003.03101-2021. Print 2022 Oct.
Results Reference
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PubMed Identifier
35203084
Citation
Nopp S, Moik F, Klok FA, Gattinger D, Petrovic M, Vonbank K, Koczulla AR, Ay C, Zwick RH. Outpatient Pulmonary Rehabilitation in Patients with Long COVID Improves Exercise Capacity, Functional Status, Dyspnea, Fatigue, and Quality of Life. Respiration. 2022;101(6):593-601. doi: 10.1159/000522118. Epub 2022 Feb 24.
Results Reference
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Effects of Respiratory Muscle Training in Individuals With Long-term Post-COVID-19 Symptoms

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