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"Inspiratory Muscle Training in Older Women"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827356
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
CARLOS MARTIN SANCHEZ, University of Salamanca

Brief Summary:
Objective: To evaluate the effectiveness of two protocols of inspiratory muscle training (IMT) in older women to improve respiratory strength, spirometric parameters and dyspnea. Low-intensity vs high-intensity resistance training programs. Evaluations: Determination of the maximum inspiratory pressure (MIP) and the maximum expiratory pressure (MEP); spirometry - maximum voluntary ventilation (MVV), peak expiratory flow (PEF), tidal volume (TV); functional capacity measured with 6 minute walk test; dyspnea using the Borg scale and clinical evaluations. The participants will be evaluated at the beginning and end of the intervention period. Intervention: There are two groups of patients, one works with low loads (20% MIP) and another with high loads (40% MIP). They train 5 days/week 15 cycles lasting 1 minute. There is a rest of 1 minute between each cycle.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: Inspiratory muscle trainer (IMT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.
Masking: Single (Investigator)
Masking Description: The principal investigator doesn´t know the group of the patients until the study ends
Primary Purpose: Treatment
Official Title: "Comparison Between Two Programs of Inspiratory Muscle Training, Low Resistance vs High Resistance, in Institutionalized Older Women"
Actual Study Start Date : April 10, 2019
Actual Primary Completion Date : June 10, 2019
Actual Study Completion Date : September 10, 2019

Arm Intervention/treatment
Experimental: "High intensity group"
Intervention is administrated with an inspiratory muscle trainer (IMT). High intensity group: 15 cycles, 1 minute each one, 40% MIP with IMT. 1 minute to rest between cycles.
Device: Inspiratory muscle trainer (IMT)
The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).

Active Comparator: "Low intensity group"
Intervention is administrated with an inspiratory muscle trainer (IMT). Low intensity group: 15 cycles, 1 minute each one, 20% MIP with IMT. 1 minute to rest between cycles.
Device: Inspiratory muscle trainer (IMT)
The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).




Primary Outcome Measures :
  1. Maximal inspiratory pressure (MIP) [ Time Frame: 2 minutes ]
    The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis. The MIP of the intervention group was assessed every 2 weeks to set the IMT workload.

  2. Maximal expiratory pressure (MEP) [ Time Frame: 2 minutes ]
    The evaluation is performed using a pressure transducer, Elka 15. It is evaluated at the beginning and at the end of the interventional phase.


Secondary Outcome Measures :
  1. Maximum voluntary ventilation (MVV) [ Time Frame: 1 minute ]
    Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: Liter (L)/Minute (min)

  2. Forced expiratory volume in the first second (FEV1) [ Time Frame: 1 minute ]
    Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L

  3. Peak expiratory flow (PEF) [ Time Frame: 1 minute ]
    Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L/second (seg)

  4. Mean expiratory flow (FEF25-75) [ Time Frame: 1 minute ]
    Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure L/seg

  5. Vital capacity (VC) [ Time Frame: 1 minute ]
    Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L

  6. Tidal volume (VT) [ Time Frame: 1 minute ]
    Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L

  7. Forced vital capacity (FVC) [ Time Frame: 1 minute ]
    Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L

  8. Functional capacity [ Time Frame: 6 minutes ]
    The 6 minutes walk test provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

  9. Dyspnea [ Time Frame: 1 minute ]
    Modified Borg scale. It is a numerical scale graduated between 0 and 10, where 0 is the minimum or without dyspnea and 10 is the maximum or extreme dyspnea.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Women
  • Older 65 years
  • Barthel > 60
  • Understand the objectives and be able to complete questionaires

Exclusion criteria:

  • Respiratory pathology during the 4 weeks prior the start of the study
  • Any complication that may impeded the performance of the evaluation tests or breathing techniques

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827356


Locations
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Spain
Carlos Martin Sanchez
Salamanca, Spain, 37006
Sponsors and Collaborators
University of Salamanca
Investigators
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Study Chair: ANA MARIA MARTIN-NOGUERAS, DR University of Salamanca
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Responsible Party: CARLOS MARTIN SANCHEZ, Principal Investigator, University of Salamanca
ClinicalTrials.gov Identifier: NCT03827356    
Other Study ID Numbers: 27112018
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CARLOS MARTIN SANCHEZ, University of Salamanca:
REHABILITATION
RESPIRATION
BREATHING EXERCISE
FATIGUE
PHYSICAL CAPACITY
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases