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

Primary Purpose

Covid19, Respiratory Muscle Training, Respiratory Function Test

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory muscle training group
Inspiratory muscle training placebo group
Inspiratory + expiratory muscle training group
Inspiratory + expiratory muscle training placebo group
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Respiratory Muscle Training, Respiratory Function Test, Quality of Life, Psychosocial Factor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UComplutenseMadrid

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Inspiratory muscle training group

Inspiratory muscle training placebo group

Inspiratory + expiratory muscle training group

Inspiratory + expiratory muscle training placebo group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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)
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.
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.
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.
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.
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.

Full Information

First Posted
December 31, 2020
Last Updated
September 29, 2021
Sponsor
Universidad Complutense de Madrid
Collaborators
Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT04734561
Brief Title
Effects of Respiratory Muscle Training in People Who Have Had COVID-19 Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
September 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double-blind randomized controlled clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Inspiratory muscle training placebo group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Inspiratory + expiratory muscle training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Inspiratory + expiratory muscle training placebo group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training group
Intervention Description
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training placebo group
Intervention Description
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
Intervention Type
Other
Intervention Name(s)
Inspiratory + expiratory muscle training group
Intervention Description
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
Intervention Type
Other
Intervention Name(s)
Inspiratory + expiratory muscle training placebo group
Intervention Description
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
Primary Outcome Measure Information:
Title
Health-related quality of life
Description
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.
Time Frame
Change from Baseline Health-related quality of life at 8 weeks
Title
Exercise tolerance
Description
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.
Time Frame
Change from Baseline Exercise tolerance at 8 weeks
Secondary Outcome Measure Information:
Title
Maximum respiratory pressures
Description
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.
Time Frame
Change from Baseline Maximum respiratory pressures at 8 weeks
Title
Inspiratory muscle endurance
Description
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)
Time Frame
Change from Baseline Inspiratory muscle endurance at 8 weeks
Title
Upper limb muscle strength
Description
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.
Time Frame
Change from Baseline Peripheral muscle strength at 8 weeks
Title
Lung function (forced spirometry)
Description
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.
Time Frame
Change from Baseline Lung function at 8 weeks
Title
Cognitive factors
Description
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.
Time Frame
Change from Baseline cognitive factors at 8 weeks
Title
Lower limb muscle strength
Description
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.
Time Frame
Change from Baseline Lower limb strength at 8 weeks
Title
Psychological factors
Description
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.
Time Frame
Change from Baseline Psychological factors at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibai López de Uralde Villanueva, PhD
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
UComplutenseMadrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32675661
Citation
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.
Results Reference
background
PubMed Identifier
32475821
Citation
Barker-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.
Results Reference
background
PubMed Identifier
32817258
Citation
Spruit 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 Aug 13;56(6):2002197. doi: 10.1183/13993003.02197-2020. Online ahead of print.
Results Reference
background
PubMed Identifier
32220590
Citation
Jimenez-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.
Results Reference
background
PubMed Identifier
32379637
Citation
Liu 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.
Results Reference
background

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

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