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IRCT20220604055072N1 IRCT 2022-11-25 Rashid Latif Medical College Combined effect of respiratory muscle stretching and active cycle breathing technique on dyspnea related kinesiophobia Combined effect of Respiratory Muscle Stretching with Active cycle Breathing Technique on dyspnea related kinesiophobia among patients with chronic obstructive pulmonary disease (COPD) 2022-11-21 anticipated 40 Complete https://irct.ir/trial/66014 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were allocated into two groups i.e.; Group A and Group B, by lottery method. Lottery method is a type of simple random sampling. In this method, each participant of the trial is assigned a unique number. In the next step these numbers are written on separate cards which are physically similar in shape, size, color etc. 60 cards were used. Then they are placed in a basket and thoroughly mixed. In the last step the slips are taken out randomly without looking at them and are placed into two sets randomly. Total of 40 cards were taken out, 20 participants in each group, Blinding description: The blinding is achieved by concealment in which the treatment allocation for each patient is not revealed to the patient. This is done to avoid biasness. N/A Chronic Obstructive Pulmonary Disease. Intervention 1: Intervention group 1: In which participants will be treated with Active Cycle Breathing Exercise (ACBT). This group will be the treated consisting of breathing control, thoracic expansion exercises, and the forced expiration technique in gravity assisted positions. In ACBT, breathing control are normal tidal volume breathing using the lower chest with relaxation of the upper chest and shoulders. Thoracic expansion exercises are deep-breathing exercises emphasizing inspiration. Inspiration is active and expiration is passive and relaxed. The cycle will be ended with the forced expiration technique consisting of huffs combined with breathing control. A huff to low lung volume will move the more peripherally situated secretions and a huff from a high lung volume will clear secretions that have reached the more proximal airways. The forced expiration technique can be explained using the concept of the equal pressure point, which is the point where the pressure within the airways is equal to the pleural pressure. Downstream of the equal pressure point, toward the mouth, the dynamic squeezing of airways allows secretions to be mobilized and cleared. As lung volume decreases equal pressure points move peripherally and a huff to low lung volume clears secretions from the peripheral airways. Secretions mobilized to the upper airways is cleared by a huff from high lung volume. Intervention 2: Intervention group 2: In which participants will be treated with Active Cycle Breathing Exercise and Respiratory Stretching Exercise (Pectoralis Major, Pectoralis Minor, Upper Trapezius, Scalene, Sternocleidomastoid, Intercostal and anterior serratus). Active Cycle Breathing Technique consist of breathing control, thoracic expansion exercises, and the forced expiration technique in gravity assisted positions. In ACBT, breathing control are normal tidal volume breathing using the lower chest with relaxation of the upper chest and shoulders. Thoracic expansion exercises are deep-breathing exercises emphasizing inspiration. Inspiration is active and expiration is passive and relaxed. The cycle will be ended with the forced expiration technique consisting of huffs combined with breathing control. A huff to low lung volume will move the more peripherally situated secretions and a huff from a high lung volume will clear secretions that have reached the more proximal airways. The forced expiration technique can be explained using the concept of the equal pressure point, which is the point where the pressure within the airways is equal to the pleural pressure. Downstream of the equal pressure point, toward the mouth, the dynamic squeezing of airways allows secretions to be mobilized and cleared. As lung volume decreases equal pressure points move peripherally and a huff to low lung volume clears secretions from the peripheral airways. Secretions mobilized to the upper airways is cleared by a huff from high lung volume. Respiratory muscles stretching will be performed passively by a physical therapist. Subjects will be in the supine or lateral position, knees bent to correct the lumbar curve, with repositioning of the scapular waist as well as scapular and arm abduction in order to prevent postural compensations. Stretching will be performed bilaterally. For Upper trapezius stretching, patient will be in supine position with lateral flexion of the head to the opposite side of that stretched, the therapist supported the occipital region with one hand and the shoulder with the other hand, causing displacement of two support points in the craniocaudal direction. For Sternocleidomastoid stretching, patient will be in supine position with lateral flexion with rotation of the head to the opposite side of that stretched; the therapist placed one hand on the occipital region and the other on the sternal region, which was displaced in the cranial-caudal direction. For Scalene stretching, patient will be in supine position, with one hand on the occipital region and the other on the sternum region, the therapist promoted displacement of the two support points, in opposite directions. For Pectoralis major stretching, patient will be in supine position, on the side to be stretched, the patient́s arm was abducted, forearm flexed and hand resting on the occipital region. The displacement was performed with one of the therapist’s hands on the upper third of the arm and the other on the lateral region of the upper chest, following the direction of muscle fibers. For intercostal and Serratus Anterior stretching patient will be in supine and lateral position on a half-moon-shaped foam roller in the infra-axillary region, forearms flexed and hands resting on the occipital region; the therapist used both palmar region hand’s to mobilize the ribs in the craniocaudal direction. Stretching will be done during the expiratory phase, with two sets of ten consecutive incursions for each muscle and a one-minute interval between the series. For intercostal muscles stretching, a side stretch was performed in lateral decubitus at the moment of inspiration and the ribs were monitored during expiration. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Fareeha Faisal
35-Km Ferozepur Road Lahore
Lahore Pakistan 54900 +92 321 4883868 drfareeha506@gmail.com Rashid Latif Medical College scientific Aleena Waheed
35-Km Ferozepur Road Lahore
Lahore Pakistan 54900 +92 321 4883868 alwaheed28@gmail.com Rashid Latif Medical College Pakistan Patients diagnosed with moderate-to-severe COPD Clinical stability (no changes in medication during the last month), No supplemental O2 dependence 40 years no limit Both Presence of comorbidities affecting ambulation/activity (e.g., severe cardiac or neurological disorders, cancer, musculoskeletal problems) History of cognitive disorders J44 Other chronic obstructive pulmonary disease Rehabilitation Rehabilitation Intervention group 1: In which participants will be treated with Active Cycle Breathing Exercise (ACBT). This group will be the treated consisting of breathing control, thoracic expansion exercises, and the forced expiration technique in gravity assisted positions. In ACBT, breathing control are normal tidal volume breathing using the lower chest with relaxation of the upper chest and shoulders. Thoracic expansion exercises are deep-breathing exercises emphasizing inspiration. Inspiration is active and expiration is passive and relaxed. The cycle will be ended with the forced expiration technique consisting of huffs combined with breathing control. A huff to low lung volume will move the more peripherally situated secretions and a huff from a high lung volume will clear secretions that have reached the more proximal airways. The forced expiration technique can be explained using the concept of the equal pressure point, which is the point where the pressure within the airways is equal to the pleural pressure. Downstream of the equal pressure point, toward the mouth, the dynamic squeezing of airways allows secretions to be mobilized and cleared. As lung volume decreases equal pressure points move peripherally and a huff to low lung volume clears secretions from the peripheral airways. Secretions mobilized to the upper airways is cleared by a huff from high lung volume. Intervention group 2: In which participants will be treated with Active Cycle Breathing Exercise and Respiratory Stretching Exercise (Pectoralis Major, Pectoralis Minor, Upper Trapezius, Scalene, Sternocleidomastoid, Intercostal and anterior serratus). Active Cycle Breathing Technique consist of breathing control, thoracic expansion exercises, and the forced expiration technique in gravity assisted positions. In ACBT, breathing control are normal tidal volume breathing using the lower chest with relaxation of the upper chest and shoulders. Thoracic expansion exercises are deep-breathing exercises emphasizing inspiration. Inspiration is active and expiration is passive and relaxed. The cycle will be ended with the forced expiration technique consisting of huffs combined with breathing control. A huff to low lung volume will move the more peripherally situated secretions and a huff from a high lung volume will clear secretions that have reached the more proximal airways. The forced expiration technique can be explained using the concept of the equal pressure point, which is the point where the pressure within the airways is equal to the pleural pressure. Downstream of the equal pressure point, toward the mouth, the dynamic squeezing of airways allows secretions to be mobilized and cleared. As lung volume decreases equal pressure points move peripherally and a huff to low lung volume clears secretions from the peripheral airways. Secretions mobilized to the upper airways is cleared by a huff from high lung volume. Respiratory muscles stretching will be performed passively by a physical therapist. Subjects will be in the supine or lateral position, knees bent to correct the lumbar curve, with repositioning of the scapular waist as well as scapular and arm abduction in order to prevent postural compensations. Stretching will be performed bilaterally. For Upper trapezius stretching, patient will be in supine position with lateral flexion of the head to the opposite side of that stretched, the therapist supported the occipital region with one hand and the shoulder with the other hand, causing displacement of two support points in the craniocaudal direction. For Sternocleidomastoid stretching, patient will be in supine position with lateral flexion with rotation of the head to the opposite side of that stretched; the therapist placed one hand on the occipital region and the other on the sternal region, which was displaced in the cranial-caudal direction. For Scalene stretching, patient will be in supine position, with one hand on the occipital region and the other on the sternum region, the therapist promoted displacement of the two support points, in opposite directions. For Pectoralis major stretching, patient will be in supine position, on the side to be stretched, the patient́s arm was abducted, forearm flexed and hand resting on the occipital region. The displacement was performed with one of the therapist’s hands on the upper third of the arm and the other on the lateral region of the upper chest, following the direction of muscle fibers. For intercostal and Serratus Anterior stretching patient will be in supine and lateral position on a half-moon-shaped foam roller in the infra-axillary region, forearms flexed and hands resting on the occipital region; the therapist used both palmar region hand’s to mobilize the ribs in the craniocaudal direction. Stretching will be done during the expiratory phase, with two sets of ten consecutive incursions for each muscle and a one-minute interval between the series. For intercostal muscles stretching, a side stretch was performed in lateral decubitus at the moment of inspiration and the ribs were monitored during expiration. Kinesiophobia. Timepoint: Pre-intervention and 2 weeks Post-intervention. Method of measurement: Tampa Scale for Kinesiophobia. Functional Capacity. Timepoint: Pre-intervention and 2 week Post-intervention. Method of measurement: 6 Minute Walk Test. Anxiety. Timepoint: Pre-intervention and 2 week Post-intervention. Method of measurement: Hospital Anxiety and Depression Scale. Rashid Latif Medical College Approved 2022-10-05 Institutional Review Board of Rashid Latif Medical College 35- km Ferozepur Road, Lahore Lahore Punjab Pakistan