"Inspiratory Muscle Training in Older Women"
Primary Purpose
Respiratory Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory muscle trainer (IMT)
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Insufficiency focused on measuring REHABILITATION, RESPIRATION, BREATHING EXERCISE, FATIGUE, PHYSICAL CAPACITY
Eligibility 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
Sites / Locations
- Carlos Martin Sanchez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
"High intensity group"
"Low intensity group"
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Maximal inspiratory pressure (MIP)
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.
Maximal expiratory pressure (MEP)
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
Maximum voluntary ventilation (MVV)
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)
Forced expiratory volume in the first second (FEV1)
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
Peak expiratory flow (PEF)
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)
Mean expiratory flow (FEF25-75)
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
Vital capacity (VC)
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
Tidal volume (VT)
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
Forced vital capacity (FVC)
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
Functional capacity
The 6 minutes walk test provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Dyspnea
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.
Full Information
NCT ID
NCT03827356
First Posted
January 28, 2019
Last Updated
October 29, 2019
Sponsor
University of Salamanca
1. Study Identification
Unique Protocol Identification Number
NCT03827356
Brief Title
"Inspiratory Muscle Training in Older Women"
Official Title
"Comparison Between Two Programs of Inspiratory Muscle Training, Low Resistance vs High Resistance, in Institutionalized Older Women"
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
September 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Participants:
Institutionalized women will be recruited to participate in an 8-week randomized trial.
All patients will be asked to carry out the 5-day weekly program, and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session. All participants signed an informed consent form.
The patients will be assigned to the two groups randomly. The main researcher doesn´t meet any of the participants until the initial assessment will be carried out.
Evaluation:
The participants are evaluated at the beginning and end of the intervention period.
The evaluation of MIP and MEP is performed using a pressure transducer, Elka 15, which obtains each measurement in millibar and converts 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 will be repeated until 3 values were obtained with a difference of less than 5%, and the highest value will be used for the analysis. The MIP of the intervention group will be assessed every 2 weeks to set the IMT workload.
Lung volumes are assessed using a spirometer (model: datospir touch) with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules will be followed [19], and the highest value of three correct measurements will be chosen. Data is collected for the following parameters: maximum voluntary ventilation (MVV), forced expiratory volume in the first second (FEV1), peak expiratory flow (PEF), mean expiratory flow (FEF25-75), vital capacity (VC), tidal volume (TV) and forced vital capacity (FVC).
Dyspnea will be measured using the modified Borg scale [20]. Functional capacity will be measured with 6 minute walk test. All evaluations will be done in the corresponding center, during the same time slot and by the same examiner for both groups.
Intervention:
"High-intensity group". The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O).
The intensity of the device will be 40% of MIP. The protocol includes 15 cycles lasting 1 minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1 minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.
"Low-intensity group".The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O).
The intensity of the device will be 20% of MIP. The protocol includes 15 cycles lasting 1 minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1 minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
REHABILITATION, RESPIRATION, BREATHING EXERCISE, FATIGUE, PHYSICAL CAPACITY
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.
Masking
Investigator
Masking Description
The principal investigator doesn´t know the group of the patients until the study ends
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"High intensity group"
Arm Type
Experimental
Arm Description
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.
Arm Title
"Low intensity group"
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle trainer (IMT)
Intervention Description
The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).
Primary Outcome Measure Information:
Title
Maximal inspiratory pressure (MIP)
Description
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.
Time Frame
2 minutes
Title
Maximal expiratory pressure (MEP)
Description
The evaluation is performed using a pressure transducer, Elka 15. It is evaluated at the beginning and at the end of the interventional phase.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Maximum voluntary ventilation (MVV)
Description
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)
Time Frame
1 minute
Title
Forced expiratory volume in the first second (FEV1)
Description
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
Time Frame
1 minute
Title
Peak expiratory flow (PEF)
Description
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)
Time Frame
1 minute
Title
Mean expiratory flow (FEF25-75)
Description
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
Time Frame
1 minute
Title
Vital capacity (VC)
Description
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
Time Frame
1 minute
Title
Tidal volume (VT)
Description
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
Time Frame
1 minute
Title
Forced vital capacity (FVC)
Description
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
Time Frame
1 minute
Title
Functional capacity
Description
The 6 minutes walk test provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time Frame
6 minutes
Title
Dyspnea
Description
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.
Time Frame
1 minute
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANA MARIA MARTIN-NOGUERAS, DR
Organizational Affiliation
University of Salamanca
Official's Role
Study Chair
Facility Information:
Facility Name
Carlos Martin Sanchez
City
Salamanca
ZIP/Postal Code
37006
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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