"Inspiratory Muscle Training in Older Women"

NCT03827356 | Completed

• 1 other identifier: 27112018
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency

Keywords

REHABILITATION; RESPIRATION; BREATHING EXERCISE; FATIGUE; PHYSICAL CAPACITY

Outcome Measures

Primary Outcomes (2)

• 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.

  2 minutes

• 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.

  2 minutes

Secondary Outcomes (9)

• Maximum voluntary ventilation (MVV)

  1 minute

• Forced expiratory volume in the first second (FEV1)

  1 minute

• Peak expiratory flow (PEF)

  1 minute

• Mean expiratory flow (FEF25-75)

  1 minute

• Vital capacity (VC)

  1 minute

Study Arms (2)

"High intensity group"

EXPERIMENTAL

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)

"Low intensity group"

ACTIVE COMPARATOR

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)

Interventions

Inspiratory muscle trainer (IMT) DEVICE

The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).

"High intensity group"; "Low intensity group"

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Carlos Martin Sanchez

Salamanca, 37006, Spain

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Aspiration; Fatigue

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• ANA MARIA MARTIN-NOGUERAS, DR

  University of Salamanca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The principal investigator doesn´t know the group of the patients until the study ends
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 1, 2019
• Study Start: April 10, 2019
• Primary Completion: June 10, 2019
• Study Completion: September 10, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)