Effects of Inspiratory Muscle Training After Covid-19 (ReCOV)

NCT05024474 | Completed

• 1 other identifier: IMT-ReCOV
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Initially, it was suspected that Covid-19 would primarily affect the airways, but several studies have now shown that it is a disease with multisystem manifestations. Covid-19 has the potential to affect physical, cognitive, and psychological functions in multiple ways. It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. The term post-acute Covid-19 syndrome (PACS) is now used to describe the wide range of prolonged symptoms following the infection. Patients who have been in hospital for Covid-19 for a long time may need specialized rehabilitation, however, also non-hospitalized patients with mild symptoms may need specific rehabilitation to be able to meet the complex symptoms and problems that may arise. Previous studies on the recovery and rehabilitation after other coronavirus shows the importance to develop tailored interventions so that these patients receive appropriate rehabilitation The aim of this study is to evaluate the effects of inspiratory muscle training on adult patients with PACS and decreased respiratory muscle strength. A randomized controlled trial will be used. A total of 90 adult patients with PACS and 80 % or less of predicted value in inspiratory muscle strength (maximal inspiratory pressure) will be eligible for enrollment. Patients will be randomized either to an intervention group or a control group. The intervention will consist of inspiratory muscle training performed twice daily for 8 weeks. This will be combined with an 8-week physical exercise training program. The control group will perform the same physical exercise training according to standard care. All measurements will be performed at baseline and after 8 weeks. Primary outcome is maximal inspiratory pressure. Secondary outcomes are: Maximal expiratory pressure, pulmonary function, physical capacity, physical activity, respiratory status and symptoms, health-related quality of life, work ability, fatigue, self-reported outcome measure of physical function and voice function. Covid-19 has the potential to affect physical, cognitive, and psychological functions in multiple ways and lead to a negative impact on quality of life in the long-term perspective. Therefore, development of a rehabilitation program with specific tailored interventions will be necessary to improve physical and psychological function, as well as health-related quality of life and work ability.

Conditions

Covid-19; Respiratory Complication; Post-Acute Covid-19 Syndrome

Keywords

Inspiratory muscle training; Physiotherapy; Rehabilitation; Maximal inspiratory pressure; Respiratory Muscle Training

Outcome Measures

Primary Outcomes (1)

• Change in Maximal Inspiratory Pressure (MIP)

  Change in MIP measured in cmH20, expressed as percentage of predictive value, with a Respiratory Pressure Meter (Micro RPM)

  Measured before and after the intervention period of 8 weeks to detect a change

Secondary Outcomes (26)

• Change in Maximal Expiratory Pressure (MEP)

  Measured before and after the intervention period of 8 weeks to detect a change

• Change in Lung function

  Measured before and after the intervention period of 8 weeks to detect a change

• Change in walking distance during 6 minute walk test, expressed as percentage of predictive value,

  Measured before and after the intervention period of 8 weeks to detect a change

• Change in oxygen saturation during 6 minute walk test

  Measured before and after the intervention period of 8 weeks to detect a change

• Change in oxygen desaturation during 6 minute walk test

  Measured before and after the intervention period of 8 weeks to detect a change

Study Arms (2)

Intervention: inspiratory muscle training + physical exercise

EXPERIMENTAL

Inspiratory muscle training (IMT) twice a day for 8 weeks combined with a physical exercise program at least two times a week for 8 weeks.

Other: Inspiratory muscle training (IMT); Other: Physical exercise

Active control: physical exercise

ACTIVE COMPARATOR

A physical exercise program at least two times a week for 8 weeks.

Other: Physical exercise

Interventions

Inspiratory muscle training (IMT) OTHER

Inspiratory muscle training (IMT) at 20-50 % of maximal inspiratory pressure (MIP), 2 x 30 repetitions, twice a day for 8 weeks.

Intervention: inspiratory muscle training + physical exercise

Physical exercise OTHER

A physical exercise program at least two times a week for 8 weeks. Including strength, aerobic and mobility exercises.

Active control: physical exercise; Intervention: inspiratory muscle training + physical exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years) who have undergone Covid-19 and have 80% or less of the lower limit of predicted value in maximal inspiratory pressure (MIP).

You may not qualify if:

• Physical och cognitive dysfunction which makes it impossible to carry out measurements and interventions. Already on-going intervention with inspiratory muscle training.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Malin Nygren Bonnier, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The interventions were not possible to mask for participants or health care professionals (physiotherapist leading interventions). The physiotherapists who performed the tests after interventions were blinded to the group allocation. All data were coded and group assignment was blinded for the outcome analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, Senior lecturer and Associate Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 27, 2021
• Study Start: August 24, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)