Different Inspiratory Muscle Trainings in Patients With COPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Yalova
About this trial
COPD is one of the most life-threatening pulmonary diseases. According to the World Health Organization, it is expected to rise to the third leading cause of death by 2030. Smoking is the most significant contributing factor. COPD reduces lung volumes and causes dyspnea. Over time, respiratory muscle weakness develops, leading to hypercapnia, dyspnea, nocturnal oxygen desaturation, and decreased exercise performance. Pulmonary rehabilitation is the most important component of COPD treatment. Respiratory muscle training should be a mandatory component of the pulmonary rehabilitation program. Combining inspiratory muscle training with functional exercises allows the focus to be on respiratory muscle functions beyond the task of breathing. The purpose of this study was to investigate the effects of Functional Inspiratory Muscle Training on the course of the disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Basic Inspiratory Muscle Training
Other interventionThe participant will complete IMT training with a physiotherapist one day a week and without a supervisor for the remaining 6 days, 15 minutes in the morning and 15 minutes in the evening.
Functional Inspiratory Muscle Training
Other interventionFollowing 4 weeks of Basic IMT, the patient will undergo 30-minute exercises and IMT, three days a week, for 4 weeks, accompanied by a physiotherapist. The patient will continue 15-minute Basic IMT training morning and evening, four days a week, without a supervisor. Exercises will be performed 8-12 times, in 2 sets, with 1-2 minute breaks. Supine chin-up position, lowering and lifting bent legs to the side, Supine chin-up position, 90° hip flexion of one leg, then sliding the heel to extend the knee and 45° straight leg raise, Supine chin-up position, 90° hip flexion of the leg in the chin-up position, Bilateral 90° hip flexion of the legs in the chin-up position, Supine chin-up position, opposite knee extension and shoulder flexion, Cross arm-leg raises in the crawling position, shoulder flexion and extension on mobile surfaces, Back slide on the wall, Lunge by stepping forward, Lifting weight from the floor and lifting it overhead, Bridging, Crunches, Modified push-up
Control
Other interventionSimple upper extremity exercises and diaphragmatic breathing exercises will be given with equipment suitable for the home environment, 1 day a week accompanied by a physiotherapist for 30 minutes, and the remaining 6 days without a supervisor for 15 minutes in the morning and 15 minutes in the evening. (8-12 repetitions, 2 sets, 1-2 minute break)
Treatment groups
51 Participants
are divided into 3 treatment groupsGroup A: Basic Inspiratory Muscle TrainingExperimental treatment 1 intervention
Group B: Functional Inspiratory Muscle TrainingExperimental treatment 1 intervention
Group C: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dyspnea Assessment
Modified Medical Research Council -mMRC: The mMRC used for dyspnea assessment consists of five stages. Stage 0 represents mild dyspnea, and Stage 4 represents severe dyspnea (Bestall et al., 1999).
Time frame
Baseline and through study completion, an average of 8 weeks2
COPD Assesment Test
COPD Assessment Test (CAT): The test consists of eight questions that examine cough, phlegm, shortness of breath, home and outdoor difficulties, sleep, and fatigue parameters. The maximum score is 40. As the score increases, symptoms worsen. The validity and reliability of the Turkish version was conducted by Yorgancıoğlu et al. (Yorgancioglu, 2012).
Time frame
Baseline and through study completion, an average of 8 weeks3
Pulmonary Function Testing
Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a seated position. Forced expiratory volume in one second (FEV1) is measured (Miller et al., 2005).
Time frame
Baseline and through study completion, an average of 8 weeks4
Pulmonary Function Testing
Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a seated position. Forced vital capacity (FVC) is measured (Miller et al., 2005).
Time frame
Baseline and through study completion, an average of 8 weeksSecondary outcomes
1
Cognitive Performance
This will be measured with the Standardized Mini Mental Test (SMMT). The Mini Mental Test, developed by Folstein et al., is used to assess an individual's cognitive performance. The maximum score a patient can achieve on the 11-question test, which includes orientation, recording memory, attention and calculation, recall, and language sections, is 30 (Folstein et al., 1975). The higher the score, the better the situation. 0-17 points indicate severe impairment, 18-23 points indicate moderate impairment, 24-26 points indicate mild cognitive impairment, and 27-30 points indicate normal levels (Creavin et al., 2016). The Turkish validity and reliability study was conducted by Güngen et al. (Güngen et al., 2002).
Time frame
Baseline and through study completion, an average of 8 weeks2
Peripheral Muscle Strength Measurement
Participants' knee extension and grip strength will be assessed. A hand-held dynamometer (Lafayette Manual Muscle Testing System; Lafayette Instrument Company, Lafayette, Indiana, USA) will be used for knee extension strength, and a Baseline BIMS Digital 5-Position Grip Dynamometer (Baseline Evaluation Instruments, USA) will be used for grip strength. Measurements are taken with the participant seated in a chair. Grip strength is measured in the standard position recommended by the American Association of Hand Therapists. Positions include shoulder adduction, forearm neutral position, elbow flexion at 90 degrees, wrist extension at 0-30 degrees, and ulnar deviation of 15 degrees (Tregdet and Davis, 2000). The best value after performing each measurement three times is recorded.
Time frame
Baseline and through study completion, an average of 8 weeks3
Balance Assessment (Berg Balance Scale-BDI)
The BDI is used to assess dynamic balance performance. It is evaluated under 14 headings, each with a score of 0-4, for a total of 0-56. 56 is the highest score and indicates complete unsupported balance performance. Scores between 0-20 represent high fall risk, 21-40 represent moderate fall risk, and 41-56 represent low fall risk. Its validity and reliability in Turkish were conducted by Şahin et al. (Sahin et al., 2008).
Time frame
Baseline and through study completion, an average of 8 weeks4
Core Muscle Assessment
The PRONE test will be performed using the Stabilizer™ (Chattanooga Group Inc., Chattanooga, TN) device. Before the test, the patient is instructed to perform an abdominal wall retraction. The device is placed under the abdomen with the patient lying prone. After the manometer pressure is set at 70 mmHg, the patient is asked to perform and maintain the abdominal wall retraction. The test is repeated three times, and the highest value is recorded (de Paula Lima et al., 2011).
Time frame
Baseline and through study completion, an average of 8 weeksSponsors and contacts
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Source ClinicalTrials.gov