Clinical trial NCT04460261: 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
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Keywords: chronic obstructive pulmonary disease
functional inspiratory muscle training
geriatric individuals
Lead sponsor: Ahi Evran University Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inspiratory muscle strength
timeFrame: 8 weeks
measure: Expiratory muscle strength
timeFrame: 8 weeks
measure: Dyspnea assessment
timeFrame: 8 weeks
measure: Symptoms assessment
timeFrame: 8 weeks
measure: Upper extremity functional exercise capacity assessment
timeFrame: 8 weeks
measure: Lower extremity functional exercise capacity assessment
timeFrame: 8 weeks
Secondary outcomes:
measure: Balance assessment
timeFrame: 8 weeks
measure: Static antero-posterior postural stability assessment
timeFrame: 8 weeks
measure: Static medio-lateral postural stability assessment
timeFrame: 8 weeks
measure: Physical activity assessment
timeFrame: 8 weeks
measure: Quality of life assessment
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Selcuk University
name: Ismail ozsoy, PhD
role: PRINCIPAL_INVESTIGATOR
References: