Covid19NCT05597774
Effects of Respiratory Muscle Training in Individuals With Long-term Post-COVID-19 Symptoms
A study testing Inspiratory + expiratory muscle training group and Exercise training program in people with Covid19 and Post-acute COVID-19 Syndrome, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19, Post-acute COVID-19 Syndrome
- What is being tested?
- Inspiratory + expiratory muscle training group and Exercise training program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 28 Oct 2022to 22 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Respiratory Muscle Training Combined With an Exercise Training Program in Individuals With Long-term Post-COVID-19 Symptoms
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.
Read the 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.
- Conditions
- Covid19, Post-acute COVID-19 Syndrome
- Being tested
- Inspiratory + expiratory muscle training group, Inspiratory + expiratory muscle training sham group, Exercise training program
- Keywords
- Respiratory Muscle Training, Tele-rehabilitation, Quality of Life, Exercise
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory + expiratory muscle training groupOther
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
Inspiratory + expiratory muscle training sham groupOther
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
Exercise training programOther
Participants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training + Inspiratory and expiratory muscle training group | Experimental | 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. Receives: Other: Inspiratory + expiratory muscle training group; Other: Exercise training program |
| Exercise training + Inspiratory and expiratory muscle training sham group | Sham comparator | 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. Receives: Other: Inspiratory + expiratory muscle training sham group; Other: Exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 1-week post-intervention (9 weeks from baseline)
Change in exercise tolerance
Change in exercise tolerance between baseline and post-intervention, as measured by a cardiopulmonary exercise test
Measured: Baseline and 1-week post-intervention (9 weeks from baseline)
Secondary outcomes (4)
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
Measured: Baseline and 1-week post-intervention (9 weeks from baseline)
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)
Measured: Baseline and 1-week post-intervention (9 weeks from baseline)
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
Measured: Baseline and 1-week post-intervention (9 weeks from baseline)
Change in psychological status
Change in anxiety/depression levels between baseline and post-intervention, as measured by Hospital Anxiety and Depression Scale
Measured: Baseline and 1-week post-intervention (9 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start28 Oct 2022
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid
- Responsible party
- Sponsor
- Investigators
- Ibai López de Uralde, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597774
- Sponsor's protocol ID
- 21/747
- Status last verified
- Sep 2022
- First submitted
- 7 Oct 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35236727Nopp 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.
PubMed 35203084Del Corral T, Fabero-Garrido R, Plaza-Manzano G, Izquierdo-Garcia J, Lopez-Saez M, Garcia-Garcia R, Lopez-de-Uralde-Villanueva I. Effect of respiratory rehabilitation on quality of life in individuals with post-COVID-19 symptoms: A randomised controlled trial. Ann Phys Rehabil Med. 2025 Feb;68(1):101920. doi: 10.1016/j.rehab.2024.101920. Epub 2025 Jan 11.
PubMed 39798250
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Muscle Training Combined With an Exercise Training Program in Individuals With Long-term Post-COVID-19 Symptoms
- ClinicalTrials.gov ID
- NCT05597774
- Acronym / sponsor ID
- 21/747
- Conditions
- Covid19, Post-acute COVID-19 Syndrome
- Keywords
- Respiratory Muscle Training, Tele-rehabilitation, Quality of Life, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training + Inspiratory and expiratory muscle training group | Experimental | Other: Inspiratory + expiratory muscle training group, Other: Exercise training programParticipants 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. |
| Exercise training + Inspiratory and expiratory muscle training sham group | Sham comparator | Other: Inspiratory + expiratory muscle training sham group, Other: Exercise training programParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory + expiratory muscle training groupParticipants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm. | Other | Exercise training + Inspiratory and expiratory muscle training group |
| Inspiratory + expiratory muscle training sham groupParticipants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm. | Other | Exercise training + Inspiratory and expiratory muscle training sham group |
| Exercise training programParticipants will perform a cardiovascular exercise program including warm-up, recovery between intervals and return to calm by cycloergometer. | Other | Exercise training + Inspiratory and expiratory muscle training group, Exercise training + Inspiratory and expiratory muscle training sham group |
Primary outcome
Change in quality of life
Time frame: Baseline and 1-week post-intervention (9 weeks from baseline)
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
Time frame: Baseline and 1-week post-intervention (9 weeks from baseline)
Change in exercise tolerance between baseline and post-intervention, as measured by a cardiopulmonary exercise test
4 secondary outcomes
Change in respiratory muscle function
Time frame: Baseline and 1-week post-intervention (9 weeks from baseline)
Change in physical function
Time frame: Baseline and 1-week post-intervention (9 weeks from baseline)
Change in pulmonary function
Time frame: Baseline and 1-week post-intervention (9 weeks from baseline)
Change in psychological status
Time frame: Baseline and 1-week post-intervention (9 weeks from baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 35236727McNarry 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.
- Background: PubMed 35203084Nopp 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.
- Derived from this study: PubMed 39798250Del Corral T, Fabero-Garrido R, Plaza-Manzano G, Izquierdo-Garcia J, Lopez-Saez M, Garcia-Garcia R, Lopez-de-Uralde-Villanueva I. Effect of respiratory rehabilitation on quality of life in individuals with post-COVID-19 symptoms: A randomised controlled trial. Ann Phys Rehabil Med. 2025 Feb;68(1):101920. doi: 10.1016/j.rehab.2024.101920. Epub 2025 Jan 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibai López de Uralde, PhD principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory + expiratory muscle training group and Exercise training program in people with Covid19 and Post-acute COVID-19 Syndrome, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: Baseline and 1-week post-intervention (9 weeks from baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597774, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.