IRCT | Combined effect of Respiratory Muscle Stretching with Active cycle Breathing Technique on dyspnea related kinesiophobia among patients with chronic obstructive pulmonary disease (COPD)

Protocol summary

Study aim: This study aim to determine the combined effect of Active cycle Breathing Technique with Respiratory Muscle Stretching on dyspnea related kinesiophobia in patients with Chronic Obstructive Pulmonary Disease
Design: The design of this study is Randomized, parallel Clinical Trial. Randomization is done by lottery method. In this method, the researcher gives each participant of the trial a number. Researchers draw numbers from the box randomly to allocate participants in two groups
Settings and conduct: This study is conducted at Arif memorial teaching hospital and Gulab Devi Chest Hospital. In this trial participants are blinded through concealment to avoid biasness
Participants/Inclusion and exclusion criteria: Inclusion criteria: Patients diagnosed with moderate-to-severe COPD clinical stability (no changes in medication during the last month), no supplemental O2 dependence Exclusion criteria: Presence of comorbidities affecting ambulation/activity (e.g., severe cardiac or neurological disorders, cancer, musculoskeletal problems) history of cognitive disorders
Intervention groups: Group A: Active Cycle Breathing Exercise Group B: Active Cycle Breathing Exercise + Respiratory Stretching Exercise (Pectoralis Major, Pectoralis Minor, Upper Trapezius, Scalene, Sternocleidomastoid, Intercostal and anterior serratus)
Main outcome variables: • Tampa Scale (Kinesiophobia) To evaluate kinesiophobia, the Tampa Scale (Kinesiophobia) is used, which consist of 17 items rated on a 4-point Likert scale: “strongly disagree (1 point),” “disagree (2 points),” “agree (3 points),” and “strongly agree (4 points).” For questions 4, 8, 12, and 16, the scores are reversed. Total scores range from 17 to 68 points, with higher scores indicating a stronger degree of Kinesiophobia. TSK’s internal consistency, retest reliability, and validity have already been confirmed.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20220604055072N1

Registration date: 2022-11-25, 1401/09/04

Registration timing: registered_while_recruiting

Last update: 2022-11-25, 1401/09/04

Update count: 0
Registration date: 2022-11-25, 1401/09/04

Registrant information: Name

Aleena Waheed

Name of organization / entity

Rashid Latif Medical College

Country

Pakistan

Phone

+92 321 4883868

Email address

alwaheed28@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-11-21, 1401/08/30
Expected recruitment end date: 2023-04-21, 1402/02/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Combined effect of Respiratory Muscle Stretching with Active cycle Breathing Technique on dyspnea related kinesiophobia among patients with chronic obstructive pulmonary disease (COPD)

Public title: Combined effect of respiratory muscle stretching and active cycle breathing technique on dyspnea related kinesiophobia
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patients diagnosed with moderate-to-severe COPD Clinical stability (no changes in medication during the last month), No supplemental O2 dependence

Exclusion criteria:

Presence of comorbidities affecting ambulation/activity (e.g., severe cardiac or neurological disorders, cancer, musculoskeletal problems) History of cognitive disorders
Age: From 40 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant

Sample size

Target sample size: 40

Randomization (investigator's opinion)

Randomized

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 (investigator's opinion)

Single blinded

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.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Institutional Review Board of Rashid Latif Medical College

Street address

35- km Ferozepur Road, Lahore

City

Lahore

Postal code

54000
Approval date: 2022-10-05, 1401/07/13
Ethics committee reference number: IRB/2022/059

Health conditions studied

1

Description of health condition studied: Chronic Obstructive Pulmonary Disease
ICD-10 code: J44
ICD-10 code description: Other chronic obstructive pulmonary disease

Primary outcomes

1

Description: Kinesiophobia
Timepoint: Pre-intervention and 2 weeks Post-intervention
Method of measurement: Tampa Scale for Kinesiophobia

Secondary outcomes

1

Description: Functional Capacity
Timepoint: Pre-intervention and 2 week Post-intervention
Method of measurement: 6 Minute Walk Test

2

Description: Anxiety
Timepoint: Pre-intervention and 2 week Post-intervention
Method of measurement: Hospital Anxiety and Depression Scale

Intervention groups

1

Description: 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.
Category: Rehabilitation

2

Description: 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.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Arif Memorial Teaching Hospital

Full name of responsible person

Fareeha Faisal

Street address

35-Km Ferozepur road Lahore

City

Lahore

Postal code

54600

Phone

+92 303 5879948

Email

drfareeha506@gmail.com

1

Sponsor: Name of organization / entity

Rashid Latif Medical College

Full name of responsible person

Aleena Waheed

Street address

25-Km Ferozepur road Lahore

City

Lahore

Postal code

54600

Phone

+92 321 4883868

Email

alwaheed28@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Rashid Latif Medical College
Proportion provided by this source: 100
Public or private sector: Private
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Rashid Latif Medical College

Full name of responsible person

Fareeha Faisal

Position

Physiotherapist

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

35-Km Ferozepur Road Lahore

City

Lahore

Province

Punjab

Postal code

54900

Phone

+92 321 4883868

Email

drfareeha506@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Rashid Latif Medical College

Full name of responsible person

Aleena Waheed

Position

Physiotherapist

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

35-Km Ferozepur Road Lahore

City

Lahore

Province

Punjab

Postal code

54900

Phone

+92 321 4883868

Email

alwaheed28@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Rashid Latif Medical college

Full name of responsible person

Aleena Waheed

Position

Physiotherapist

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

35-Km Ferozepur road Lahore

City

Lahore

Province

Punjab

Postal code

54900

Phone

+92 321 4883868

Email

alwaheed28@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Combined effect of Respiratory Muscle Stretching with Active cycle Breathing Technique on dyspnea related kinesiophobia among patients with chronic obstructive pulmonary disease (COPD)