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
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
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
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
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The Effects of 'Functional' Inspiratory Muscle Training
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