Effects of Respiratory Muscle Training in People Who Have Had COVID-19 Disease

September 29, 2021 updated by: Ibai López de Uralde Villanueva, Universidad Complutense de Madrid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • UComplutenseMadrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive diagnosis of COVID-19 (SARS-CoV2)
  • Hospital admission for COVID-19 in the last 3 months
  • Stable phase and home discharge;

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Inspiratory muscle training group
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.
Other: Inspiratory muscle training group
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
SHAM_COMPARATOR: Inspiratory muscle training placebo group
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.
Other: Inspiratory muscle training placebo group
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
EXPERIMENTAL: Inspiratory + expiratory muscle training group
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.
Other: Inspiratory + expiratory muscle training group
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
SHAM_COMPARATOR: Inspiratory + expiratory muscle training placebo group
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.
Other: Inspiratory + expiratory muscle training placebo group
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline Health-related quality of life at 8 weeks
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.
Change from Baseline Exercise tolerance at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum respiratory pressures
Time Frame: Change from Baseline Maximum respiratory pressures at 8 weeks
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.
Change from Baseline Maximum respiratory pressures at 8 weeks
Inspiratory muscle endurance
Time Frame: Change from Baseline Inspiratory muscle endurance at 8 weeks
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)
Change from Baseline Inspiratory muscle endurance at 8 weeks
Upper limb muscle strength
Time Frame: Change from Baseline Peripheral muscle strength at 8 weeks
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.
Change from Baseline Peripheral muscle strength at 8 weeks
Lung function (forced spirometry)
Time Frame: Change from Baseline Lung function at 8 weeks
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.
Change from Baseline Lung function at 8 weeks
Cognitive factors
Time Frame: Change from Baseline cognitive factors at 8 weeks
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.
Change from Baseline cognitive factors at 8 weeks
Lower limb muscle strength
Time Frame: Change from Baseline Lower limb strength at 8 weeks
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.
Change from Baseline Lower limb strength at 8 weeks
Psychological factors
Time Frame: Change from Baseline Psychological factors at 8 weeks
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.
Change from Baseline Psychological factors at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Collaborators

Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain

Investigators

  • Principal Investigator: Ibai López de Uralde Villanueva, PhD, Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2021

Primary Completion (ACTUAL)

July 31, 2021

Study Completion (ACTUAL)

September 29, 2021

Study Registration Dates

First Submitted

December 31, 2020

First Submitted That Met QC Criteria

January 30, 2021

First Posted (ACTUAL)

February 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/715-E_BS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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