search
Back to results

The Effects of 'Functional' Inspiratory Muscle Training

Primary Purpose

Exercise

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional Inspiratory Muscle Training
Sponsored by
Ismail OZSOY
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise focused on measuring chronic obstructive pulmonary disease, functional inspiratory muscle training, geriatric individuals

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosing COPD in accordance with Global initiative for chronic obstructive pulmonary disease (GOLD) guideline criteria
  • Being over 65 years old
  • Being a stable clinical condition (same medication routine for the past 3 weeks without taking any antibiotics)
  • Independent mobilization
  • Note: Normal spirometry values set as the inclusion criteria for non-COPD group.

Exclusion Criteria:

  • Orthopaedic problems
  • Neurological problems
  • Cognitive problems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    COPD Group

    Non-COPD Group

    Arm Description

    Patients with COPD

    Non-COPD

    Outcomes

    Primary Outcome Measures

    Inspiratory muscle strength
    Inspiratory muscle strength (MIP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values <10%) were performed and the highest value was recorded.
    Expiratory muscle strength
    Expiratory muscle strength (MEP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values <10%) were performed and the highest value was recorded.
    Dyspnea assessment
    The Modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate dyspnea. Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.
    Symptoms assessment
    The COPD Assessment Test (CAT) was used to assess symptoms in patients with COPD. It is a reliable test to evaluate the impact of COPD on a patient's health status. It has eight items and the score ranges from 0 to 40. Higher scores indicate increased symptoms.
    Upper extremity functional exercise capacity assessment
    The 6-Minute Pegboard and Ring Test was used to assess upper extremity functional exercise capacity assessment
    Lower extremity functional exercise capacity assessment
    The 6-Minute Walking Test (6MWT) was used to assess lower extremity functional exercise capacity assessment.

    Secondary Outcome Measures

    Balance assessment
    Balance was assessed using Berg Balance Scale (BBS). This scale consists of 14 items and each item is scored between 0 and 4. A higher score indicates better balance.
    Static antero-posterior postural stability assessment
    A portable balance device (Biodex Biosway Portable Balance System, New York, USA) was used to measure static antero-posterior postural stability.A higher score indicates a lower level of postural control.
    Static medio-lateral postural stability assessment
    A portable balance device (Biodex Biosway Portable Balance System, New York, USA) was used to measure static medio-lateral postural stability. A higher score indicates a lower level of postural control.
    Physical activity assessment
    Physical activity was assessed using the Physical Activity Scale for the Elderly (PASE). It is a validated 12-item self-administered scale in which higher scores indicate increased physical activity.The overall PASE score ranges from 0 to 400 or more and high scores show better physical activity levels.
    Quality of life assessment
    The quality of life was assessed using the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD). This questionnaire consists of 24 items in six different domains and higher scores indicate better quality of life.

    Full Information

    First Posted
    July 2, 2020
    Last Updated
    July 6, 2020
    Sponsor
    Ismail OZSOY
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04460261
    Brief Title
    The Effects of 'Functional' Inspiratory Muscle Training
    Official Title
    The Effects of a New Integrated Exercise Program Called 'Functional' Inspiratory Muscle Training in Geriatric Individuals With and Without Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    January 15, 2018 (Actual)
    Study Completion Date
    January 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ismail OZSOY

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study was designed as a prospective and experimental study. Geriatric individuals (age ≥ 65 years) with COPD and non-COPD were included in the study. Training program was identical for both groups and consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT. Respiratory muscle strength, symptoms, exercise capacity, balance, postural control, physical activity and quality of life were evaluated.
    Detailed Description
    The incidence of chronic obstructive pulmonary disease (COPD), which is one of the most important causes of worldwide mortality and morbidity, increases with age and the disease worsens with the effects of aging. The effects of COPD are not only limited to the lungs, it also affects other organs and systems, causing loss of strength in the respiratory muscles. Respiratory muscles are the skeletal muscles that must maintain their continuous activities for the continuity of life. Just like other skeletal muscles, the respiratory muscles can also be trained based on the principles of exercise. Inspiratory muscle training (IMT) is an exercise method used in both patients with COPD and the elderly population. Studies have shown that IMT has positive effects in COPD and elderly individuals. However, in all these studies IMT applications (also known as "foundation or conventional IMT") focus only on the respiratory task of the respiratory muscles. Nevertheless, in addition to their basic task of respiration, respiratory muscles are also involved in core stabilization and postural control.The aim of this study was to create an integrated IMT program for geriatric individuals with and without COPD and investigate its effects. The participants were divided into two groups as individuals with and without COPD. A total of 8 weeks of IMT was applied for both groups using a threshold pressure loading device The participants were asked to perform IMT twice a day in the morning and evening. Both groups were trained 3 days a week under the supervision of a physiotherapist and other days of the week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT.The intensity of the exercise was adjusted to 40-50% of the MIP. After 10 consecutive breathing cycles, the participants were asked to perform 3-4 breathe controls. As the tolerance increased, consecutive respiratory cycles were increased. The intensity of MIP was adjusted by weekly MIP measurements. Currently, foundation IMT is commonly used to train respiratory muscles. In the present study, foundation IMT was applied during the first 4 weeks of training. The participants were asked to sit in a comfortable upright position. Then the nose clip was placed, and the patients were instructed to tighten their lips around the mouthpiece and breathe against the resistance. During this 4-week-long training, all IMT applications were performed solely in a sitting position, without any loading in other positions. Following the foundation IMT, all participants underwent four weeks of functional IMT. Initially, all participants were taught diaphragmatic breathing and activating abdominal wall musculature. Each training session started with warm-up exercises and ended with cool-down exercises. During the loading phase, core stability, dynamic trunk activation and postural control exercises were applied together with IMT.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exercise
    Keywords
    chronic obstructive pulmonary disease, functional inspiratory muscle training, geriatric individuals

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study was designed as a prospective and experimental study. The participants were divided into two groups as geriatric individuals with and without chronic obstructive pulmonary disease (COPD). Both groups were trained 3 days a week under the supervision of a physiotherapist and other days of the week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT.
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COPD Group
    Arm Type
    Experimental
    Arm Description
    Patients with COPD
    Arm Title
    Non-COPD Group
    Arm Type
    Experimental
    Arm Description
    Non-COPD
    Intervention Type
    Other
    Intervention Name(s)
    Functional Inspiratory Muscle Training
    Intervention Description
    Both groups were trained 3 days a week under the supervision of a physiotherapist and other days of the week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT. Foundation IMT was applied during the first 4 weeks of training. The participants were asked to sit in a comfortable upright position. Following the foundation IMT, all participants underwent four weeks of functional IMT. Initially, all participants were taught diaphragmatic breathing and activating abdominal wall musculature. Each training session started with warm-up exercises and ended with cool-down exercises. During the loading phase, core stability, dynamic trunk activation and postural control exercises were applied together with IMT.
    Primary Outcome Measure Information:
    Title
    Inspiratory muscle strength
    Description
    Inspiratory muscle strength (MIP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values <10%) were performed and the highest value was recorded.
    Time Frame
    8 weeks
    Title
    Expiratory muscle strength
    Description
    Expiratory muscle strength (MEP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values <10%) were performed and the highest value was recorded.
    Time Frame
    8 weeks
    Title
    Dyspnea assessment
    Description
    The Modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate dyspnea. Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.
    Time Frame
    8 weeks
    Title
    Symptoms assessment
    Description
    The COPD Assessment Test (CAT) was used to assess symptoms in patients with COPD. It is a reliable test to evaluate the impact of COPD on a patient's health status. It has eight items and the score ranges from 0 to 40. Higher scores indicate increased symptoms.
    Time Frame
    8 weeks
    Title
    Upper extremity functional exercise capacity assessment
    Description
    The 6-Minute Pegboard and Ring Test was used to assess upper extremity functional exercise capacity assessment
    Time Frame
    8 weeks
    Title
    Lower extremity functional exercise capacity assessment
    Description
    The 6-Minute Walking Test (6MWT) was used to assess lower extremity functional exercise capacity assessment.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Balance assessment
    Description
    Balance was assessed using Berg Balance Scale (BBS). This scale consists of 14 items and each item is scored between 0 and 4. A higher score indicates better balance.
    Time Frame
    8 weeks
    Title
    Static antero-posterior postural stability assessment
    Description
    A portable balance device (Biodex Biosway Portable Balance System, New York, USA) was used to measure static antero-posterior postural stability.A higher score indicates a lower level of postural control.
    Time Frame
    8 weeks
    Title
    Static medio-lateral postural stability assessment
    Description
    A portable balance device (Biodex Biosway Portable Balance System, New York, USA) was used to measure static medio-lateral postural stability. A higher score indicates a lower level of postural control.
    Time Frame
    8 weeks
    Title
    Physical activity assessment
    Description
    Physical activity was assessed using the Physical Activity Scale for the Elderly (PASE). It is a validated 12-item self-administered scale in which higher scores indicate increased physical activity.The overall PASE score ranges from 0 to 400 or more and high scores show better physical activity levels.
    Time Frame
    8 weeks
    Title
    Quality of life assessment
    Description
    The quality of life was assessed using the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD). This questionnaire consists of 24 items in six different domains and higher scores indicate better quality of life.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Diagnosing COPD in accordance with Global initiative for chronic obstructive pulmonary disease (GOLD) guideline criteria Being over 65 years old Being a stable clinical condition (same medication routine for the past 3 weeks without taking any antibiotics) Independent mobilization Note: Normal spirometry values set as the inclusion criteria for non-COPD group. Exclusion Criteria: Orthopaedic problems Neurological problems Cognitive problems
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ismail ozsoy, PhD
    Organizational Affiliation
    Selcuk University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of 'Functional' Inspiratory Muscle Training

    We'll reach out to this number within 24 hrs