Covid19NCT04734561
Effects of Respiratory Muscle Training in People Who Have Had COVID-19 Disease
A study testing Inspiratory muscle training group and Inspiratory + expiratory muscle training group in people with Covid19 and Respiratory Muscle Training, 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 applied by telerehabilitation on quality of life and exercise tolerance in people who have had the COVID-19 disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Respiratory Muscle Training, Respiratory Function Test
- What is being tested?
- Inspiratory muscle training group and Inspiratory + expiratory muscle training group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2021to 29 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive diagnosis of COVID-19 (SARS-CoV2)
- Hospital admission for COVID-19 in the last 3 months
- Stable phase and home discharge;
Who cannot join
- Severe cognitive impairment
- Any type of musculoskeletal, neurological, cardiac or respiratory disease where training is contraindicated
- Inability to carry out the training program through telematic supervision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Respiratory Muscle Training on Quality of Life, Physical and Pulmonary Function and Psychological Status in Patients Who Have Had COVID-19 Disease
The main objective of the present study is to observe the short-term effects of respiratory muscle training applied by telerehabilitation on quality of life and exercise tolerance in people who have had the COVID-19 disease. As secondary objectives, the effects on respiratory muscles strength/tolerance, pulmonary function and psychological and cognitive factors.
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) Inspiratory muscle training, 2) Placebo Inspiratory muscle training, 3) Inspiratory muscle training + Expiratory muscle training, 4) Placebo Inspiratory muscle training + Expiratory muscle training.
Each exercise training program will be applied twice per day 7 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, at the end of the 4th week, and post-intervention assessments at the end of the 8th week.
- Conditions
- Covid19, Respiratory Muscle Training, Respiratory Function Test, Quality of Life, Psychosocial Factor
- Being tested
- Inspiratory muscle training group, Inspiratory muscle training placebo group, Inspiratory + expiratory muscle training group, Inspiratory + expiratory muscle training placebo group
- Keywords
- COVID-19, Respiratory Muscle Training, Respiratory Function Test, Quality of Life, Psychosocial Factor
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training groupOther
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
Inspiratory muscle training placebo groupOther
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
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 placebo groupOther
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training group | Experimental | Participants will perform an inspiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform. Receives: Other: Inspiratory muscle training group |
| Inspiratory muscle training placebo group | Sham comparator | Participants will perform an inspiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform. Receives: Other: Inspiratory muscle training placebo group |
| Inspiratory + expiratory muscle training group | Experimental | Participants will perform an inspiratory and expiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform. Receives: Other: Inspiratory + expiratory muscle training group |
| Inspiratory + expiratory muscle training placebo group | Sham comparator | Participants will perform an inspiratory and expiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform. Receives: Other: Inspiratory + expiratory muscle training placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
To evaluate the health-related quality of life of the participants a valid, reliable and generic questionnaire will be used. It consisted of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension.
Measured: Change from Baseline Health-related quality of life at 8 weeks
Exercise tolerance
Exercise tolerance will be evaluated by a test consisted on 30 squats based on three different heart rate measuring moments (resting heart rate, heart rate after exercise, heart rate after longer period) evaluating the speed at which the heart rate increases/decreases.
Measured: Change from Baseline Exercise tolerance at 8 weeks
Secondary outcomes (7)
Maximum respiratory pressures
The maximum respiratory pressures (MIP and MEP) will be measure with a device. This device applies an inspiratory/expiratory load which provides a resistance. The maneuver will be perform in a sitting position. Measuring a minimum of 3 times will be perform, recording the highest value.
Measured: Change from Baseline Maximum respiratory pressures at 8 weeks
Inspiratory muscle endurance
To measure inspiratory muscle endurance, The subjects inspire from a threshold valve beginning with pressures of 30% of MIP. The threshold pressure is then increased 10% of MIP until the load cannot be tolerated for 2 minutes. The maximum inspiratory mouth pressure that can be tolerated for the full 2-minute interval is considered the peak pressure (Ppeak)
Measured: Change from Baseline Inspiratory muscle endurance at 8 weeks
Upper limb muscle strength
To measure peripheral muscle strength the isometric strength of the hand and forearm will be evaluated through a valid and reliable tool. Three separate tests will be administered for each arm and the highest value in kilograms will be recorded.
Measured: Change from Baseline Peripheral muscle strength at 8 weeks
Lung function (forced spirometry)
The Spirometry will be perform according to American Thoracic Society criteria and was measured in liters. The maneuver will be perform 3 times and recording the best one.
Measured: Change from Baseline Lung function at 8 weeks
Cognitive factors
A validated cognitive scale will be assessed in all study participants with acceptable psychometric properties to evaluate cognitive factors. Unit of Measure: Units on a Scale where higher values represent a greater impact.
Measured: Change from Baseline cognitive factors at 8 weeks
Lower limb muscle strength
A practical, reliable and valid field test consisted on to complete as many sit-to-stand cycles as possible on a chair during a frame time.
Measured: Change from Baseline Lower limb strength at 8 weeks
Psychological factors
A validated anxiety, depression and stress scale will be assessed in all study participants with acceptable psychometric properties to evaluate anxiety and stress factors. Unit of Measure: Units on a Scale where higher values represent a greater impact. These measurements will be aggregated to arrive at one reported value of the impact of Psychological factors.
Measured: Change from Baseline Psychological factors at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start8 Feb 2021
- Primary completion31 Jul 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Model description
- double-blind randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 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
- Principal investigator, Ibai López de Uralde Villanueva, Universidad Complutense de Madrid
- Investigators
- Ibai López de Uralde Villanueva, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734561
- Sponsor's protocol ID
- 20/715-E_BS
- Status last verified
- Sep 2021
- First submitted
- 31 Dec 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Disser NP, De Micheli AJ, Schonk MM, Konnaris MA, Piacentini AN, Edon DL, Toresdahl BG, Rodeo SA, Casey EK, Mendias CL. Musculoskeletal Consequences of COVID-19. J Bone Joint Surg Am. 2020 Jul 15;102(14):1197-1204. doi: 10.2106/JBJS.20.00847.
PubMed 32675661Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
PubMed 32475821Spruit MA, Holland AE, Singh SJ, Tonia T, Wilson KC, Troosters T. COVID-19: interim guidance on rehabilitation in the hospital and post-hospital phase from a European Respiratory Society- and American Thoracic Society-coordinated international task force. Eur Respir J. 2020 Dec 3;56(6):2002197. doi: 10.1183/13993003.02197-2020. Print 2020 Dec.
PubMed 32817258Jimenez-Pavon D, Carbonell-Baeza A, Lavie CJ. Physical exercise as therapy to fight against the mental and physical consequences of COVID-19 quarantine: Special focus in older people. Prog Cardiovasc Dis. 2020 May-Jun;63(3):386-388. doi: 10.1016/j.pcad.2020.03.009. Epub 2020 Mar 24. No abstract available.
PubMed 32220590Liu 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.
PubMed 32379637Palacios-Cena D, Bautista-Villaecija O, Gueita-Rodriguez J, Garcia-Bravo C, Perez-Corrales J, Del Corral T, Lopez-de-Uralde-Villanueva I, Fabero-Garrido R, Plaza-Manzano G. Supervised Telerehabilitation and Home-Based Respiratory Muscle Training for Post-COVID-19 Condition Symptoms: A Nested Qualitative Study Exploring the Perspectives of Participants in a Randomized Controlled Trial. Phys Ther. 2024 May 1;104(5):pzae043. doi: 10.1093/ptj/pzae043.
PubMed 38507659
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Muscle Training on Quality of Life, Physical and Pulmonary Function and Psychological Status in Patients Who Have Had COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04734561
- Acronym / sponsor ID
- 20/715-E_BS
- Conditions
- Covid19, Respiratory Muscle Training, Respiratory Function Test, Quality of Life, Psychosocial Factor
- Keywords
- COVID-19, Respiratory Muscle Training, Respiratory Function Test, Quality of Life, Psychosocial Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 2 Feb 2021 (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 applied by telerehabilitation on quality of life and exercise tolerance in people who have had the COVID-19 disease. As secondary objectives, the effects on respiratory muscles strength/tolerance, pulmonary function and psychological and cognitive factors.
Detailed description
It is a double-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: 1) Inspiratory muscle training, 2) Placebo Inspiratory muscle training, 3) Inspiratory muscle training + Expiratory muscle training, 4) Placebo Inspiratory muscle training + Expiratory muscle training.
Each exercise training program will be applied twice per day 7 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, at the end of the 4th week, and post-intervention assessments at the end of the 8th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- double-blind randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training group | Experimental | Other: Inspiratory muscle training groupParticipants will perform an inspiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform. |
| Inspiratory muscle training placebo group | Sham comparator | Other: Inspiratory muscle training placebo groupParticipants will perform an inspiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform. |
| Inspiratory + expiratory muscle training group | Experimental | Other: Inspiratory + expiratory muscle training groupParticipants will perform an inspiratory and expiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform. |
| Inspiratory + expiratory muscle training placebo group | Sham comparator | Other: Inspiratory + expiratory muscle training placebo groupParticipants will perform an inspiratory and expiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Positive diagnosis of COVID-19 (SARS-CoV2)
- Hospital admission for COVID-19 in the last 3 months
- Stable phase and home discharge;
Key exclusion criteria (3 listed)
- Severe cognitive impairment
- Any type of musculoskeletal, neurological, cardiac or respiratory disease where training is contraindicated
- Inability to carry out the training program through telematic supervision.
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 muscle training groupParticipants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm. | Other | Inspiratory muscle training group |
| Inspiratory muscle training placebo groupParticipants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm. | Other | Inspiratory muscle training placebo group |
| Inspiratory + expiratory muscle training groupParticipants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm. | Other | Inspiratory + expiratory muscle training group |
| Inspiratory + expiratory muscle training placebo groupParticipants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm. | Other | Inspiratory + expiratory muscle training placebo group |
Primary outcome
Health-related quality of life
Time frame: Change from Baseline Health-related quality of life at 8 weeks
To evaluate the health-related quality of life of the participants a valid, reliable and generic questionnaire will be used. It consisted of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension.
Exercise tolerance
Time frame: Change from Baseline Exercise tolerance at 8 weeks
Exercise tolerance will be evaluated by a test consisted on 30 squats based on three different heart rate measuring moments (resting heart rate, heart rate after exercise, heart rate after longer period) evaluating the speed at which the heart rate increases/decreases.
7 secondary outcomes
Maximum respiratory pressures
Time frame: Change from Baseline Maximum respiratory pressures at 8 weeks
Inspiratory muscle endurance
Time frame: Change from Baseline Inspiratory muscle endurance at 8 weeks
Upper limb muscle strength
Time frame: Change from Baseline Peripheral muscle strength at 8 weeks
Lung function (forced spirometry)
Time frame: Change from Baseline Lung function at 8 weeks
Cognitive factors
Time frame: Change from Baseline cognitive factors at 8 weeks
Lower limb muscle strength
Time frame: Change from Baseline Lower limb strength at 8 weeks
Psychological factors
Time frame: Change from Baseline Psychological factors at 8 weeks
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 30 Sep 2021.
- Background: PubMed 32675661Disser NP, De Micheli AJ, Schonk MM, Konnaris MA, Piacentini AN, Edon DL, Toresdahl BG, Rodeo SA, Casey EK, Mendias CL. Musculoskeletal Consequences of COVID-19. J Bone Joint Surg Am. 2020 Jul 15;102(14):1197-1204. doi: 10.2106/JBJS.20.00847.
- Background: PubMed 32475821Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
- Background: PubMed 32817258Spruit MA, Holland AE, Singh SJ, Tonia T, Wilson KC, Troosters T. COVID-19: interim guidance on rehabilitation in the hospital and post-hospital phase from a European Respiratory Society- and American Thoracic Society-coordinated international task force. Eur Respir J. 2020 Dec 3;56(6):2002197. doi: 10.1183/13993003.02197-2020. Print 2020 Dec.
- Background: PubMed 32220590Jimenez-Pavon D, Carbonell-Baeza A, Lavie CJ. Physical exercise as therapy to fight against the mental and physical consequences of COVID-19 quarantine: Special focus in older people. Prog Cardiovasc Dis. 2020 May-Jun;63(3):386-388. doi: 10.1016/j.pcad.2020.03.009. Epub 2020 Mar 24. No abstract available.
- Background: PubMed 32379637Liu 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.
- Derived from this study: PubMed 38507659Palacios-Cena D, Bautista-Villaecija O, Gueita-Rodriguez J, Garcia-Bravo C, Perez-Corrales J, Del Corral T, Lopez-de-Uralde-Villanueva I, Fabero-Garrido R, Plaza-Manzano G. Supervised Telerehabilitation and Home-Based Respiratory Muscle Training for Post-COVID-19 Condition Symptoms: A Nested Qualitative Study Exploring the Perspectives of Participants in a Randomized Controlled Trial. Phys Ther. 2024 May 1;104(5):pzae043. doi: 10.1093/ptj/pzae043.
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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 Villanueva, 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 muscle training group and Inspiratory + expiratory muscle training group in people with Covid19 and Respiratory Muscle Training, 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 3 inclusion and 3 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 30 Sep 2021. 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?
Health-related quality of life (time frame: Change from Baseline Health-related quality of life at 8 weeks). 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 NCT04734561, which also lists 6 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 30 Sep 2021.