- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04460261
The Effects of 'Functional' Inspiratory Muscle Training
The Effects of a New Integrated Exercise Program Called 'Functional' Inspiratory Muscle Training in Geriatric Individuals With and Without Chronic Obstructive Pulmonary Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COPD Group
Patients with 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.
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.
|
Experimental: Non-COPD Group
Non-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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inspiratory muscle strength
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Expiratory muscle strength
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Dyspnea assessment
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Symptoms assessment
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Upper extremity functional exercise capacity assessment
Time Frame: 8 weeks
|
The 6-Minute Pegboard and Ring Test was used to assess upper extremity functional exercise capacity assessment
|
8 weeks
|
Lower extremity functional exercise capacity assessment
Time Frame: 8 weeks
|
The 6-Minute Walking Test (6MWT) was used to assess lower extremity functional exercise capacity assessment.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance assessment
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Static antero-posterior postural stability assessment
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Static medio-lateral postural stability assessment
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Physical activity assessment
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Quality of life assessment
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ismail ozsoy, PhD, Selcuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20201987
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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