Clinical trial NCT05597774: 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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Post-acute COVID-19 Syndrome
Keywords: Respiratory Muscle Training
Tele-rehabilitation
Quality of Life
Exercise
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
First posted: 2022-10-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in quality of life
timeFrame: Baseline and 1-week post-intervention (9 weeks from baseline)
measure: Change in exercise tolerance
timeFrame: Baseline and 1-week post-intervention (9 weeks from baseline)
Secondary outcomes:
measure: Change in respiratory muscle function
timeFrame: Baseline and 1-week post-intervention (9 weeks from baseline)
measure: Change in physical function
timeFrame: Baseline and 1-week post-intervention (9 weeks from baseline)
measure: Change in pulmonary function
timeFrame: Baseline and 1-week post-intervention (9 weeks from baseline)
measure: Change in psychological status
timeFrame: Baseline and 1-week post-intervention (9 weeks from baseline)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre de Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Ibai López de Uralde, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.