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Trial registered on ANZCTR


Registration number
ACTRN12624000988550
Ethics application status
Approved
Date submitted
12/07/2024
Date registered
13/08/2024
Date last updated
1/12/2024
Date data sharing statement initially provided
13/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel approach on pulmonary rehabilitation for Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) global initiative for chronic obstructive lung disease (GOLD) 1 - 3: A single-blinded randomised controlled trial protocol
Scientific title
Effectiveness of autogenic drainage and walking exercise on pain scale, dyspnea level, lung volumes, aerobic capacity and QOL among patients with AECOPD
Secondary ID [1] 312518 0
NIL KNOWN
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
AECOPD 334389 0
Condition category
Condition code
Respiratory 331029 331029 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 331030 331030 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 62 AECOPD inpatients (Participants) of GOLD 1 - GOLD 3 category at Mahkota Medical Centre, Malaysia will be participated, according to inclusion and exclusion criteria in this study. The participants were randomised and allocated to both controlled and experimental group which consist of 31 participants each.

The baseline assessment consist of four outcome measures namely, pain VAS scale, Modified BORG dyspnea scale, lung volumes and 6 minute walking test (6MWT). Since this study involves vulnerable hospitalised patients prior to lung infections, both blinded assessor and principal researcher should always be in their full personal protective equipment (PPE) throughout this study, to prevent cross -infection. This step is highly essential for infection control measures.

Before starting the baseline assessment, a bronchodilator test (BDT) administering nebulized 2.5 mg salbutamol and 0.5 mg ipratropium bromide will be given to the patient. This step is important to ensure any improvement in airflow and lung capacity after taking the bronchodilator medicine. The patient’s vital signs, including blood pressure, heart rate, oxygen saturation and respiratory rate will be recorded. Before starting the 6MWT, the blinded assessor will measure the patient’s pain VAS scale and dyspnea level.

The patient will walk along the corridor between two cones that have been marked for six minutes. During this time, heart rate and SpO2 were monitored by portable pulse oximetry (RS PRO Oxygen Oximeter Pulse Oximeter) throughout and recorded before, every 30 seconds and test completion. Dyspnea was recorded on test completion by Modified BORG Dsypnea Scale. Lastly, participant will answer the SGRQ-CM to evaluate each QOL factors.

The pre- and post-intervention assessments will take place at the patient’s room in the ward to minimize the environment factor that may influence patient’s performance. Pre-assessment will be done one day before the intervention starts.

Participants in experimental group receive autogenic drainage and walking exercise as treatment which will be carried out estimated duration of 45 minutes to 60 minutes for each session, twice per day for four consecutive days, as inpatient.

During performing autogenic drainage session, participants will be seated upright in a chair with back supported. The upper airways are cleared from secretions by huffing or blowing the nose. The researcher sits at the side and slightly behind the participant, closes enough to hear the participant's breathing. Participant hands are place on the abdomen to feel the exertion of abdominal muscles and the researcher hand is place on the upper chest to feel the secretions. The technique includes unsticking, collecting and evacuating phases. A series of 10 -20 breaths at low lung volume of inhalation will be done slowly through the nose using diaphragm and at 2-3 seconds inspiration breath hold allowing collateral ventilation to get air behind the secretions. Cough and huff are encouraged at this phase. Exhalation is done through the mouth. The vibration of mucus will be felt by researcher's hand and is place on upper chest then the patient will be asked to breath at normal tidal volume followed by for 10 -12 breaths followed by breathing near the vital capacity. The frequency of the vibrations reveals their locations. High frequency reveals secretions located in small airways. Low frequencies mean that secretions is move to larger airways. At the end of session, the mucus is evacuated by a stronger or maximum expiration or a high-volume huff or cough. A review of each patient record is essential as to assess any adherence if applicable.

For walking exercise prescription, applying the standardized moderate intensity exercise (64-76% of their age predicted maximal heart rate (APMHR)) (Kyral et al., 2019), will be measured using the equation HRmax = 220 - age (Shookster et al., 2020), adjacent to each patient’s Modified Borg Dyspnea Level (MBS). Participant will be set to portable pulse oximetry while performing walking exercise to observe the heart rate. Subsequently, participants will be asked to walk along ward corridor (100metre), back and forth, for two rounds with physiotherapist (researcher) supervision, twice per day. Participant will be asked to stop immediately if exceeding maximal heart rate within moderate intensity. No time and distance are required to be recorded during this session.

Post intervention assessments are taken after completion of four days with twice sessions per day intervention course, consist of pain VAS scale, Modified BORG Dyspnea Scale, lung volumes and 6MWT.

The participants will be later followed up a month (4 weeks) post discharge via phone call. During the phone call, researcher will ask participants based on the St George’s respiratory questionnaire for COPD, Malaysian version (SQRQ- CM). The SQRQ-CM will evaluate (component) the QOL by the. St George’s respiratory questionnaire for COPD, Malaysian version (SQRQ- CM) was used for this study.
Intervention code [1] 329037 0
Rehabilitation
Intervention code [2] 329151 0
Treatment: Other
Comparator / control treatment
A total of 62 AECOPD inpatients (Participants) of GOLD 1 - GOLD 3 category at Mahkota Medical Centre, Malaysia will be participated, according to inclusion and exclusion criteria in this study. The participants were randomised and allocated to both controlled and experimental group which consist of 31 participants each.

The baseline assessment consist of four outcome measures namely, pain VAS scale, Modified BORG dyspnea scale, lung volumes and 6 minute walking test (6MWT). Since this study involves vulnerable hospitalised patients prior to lung infections, both blinded assessor and principal researcher should always be in their full personal protective equipment (PPE) throughout this study, to prevent cross -infection. This step is highly essential for infection control measures.

Before starting the baseline assessment, a bronchodilator test (BDT) administering nebulized 2.5 mg salbutamol and 0.5 mg ipratropium bromide will be given to the patient. This step is important to ensure any improvement in airflow and lung capacity after taking the bronchodilator medicine. The patient’s vital signs, including blood pressure, heart rate, oxygen saturation and respiratory rate will be recorded. Before starting the 6MWT, the blinded assessor will measure the patient’s pain VAS scale and dyspnea level.

The patient will walk along the corridor between two cones that have been marked for six minutes. During this time, heart rate and SpO2 were monitored by portable pulse oximetry (RS PRO Oxygen Oximeter Pulse Oximeter) throughout and recorded before, every 30 seconds and test completion. Dyspnea was recorded on test completion by Modified BORG Dsypnea Scale. Lastly, participant will answer the SGRQ-CM to evaluate each QOL factors.

The pre- and post-intervention assessments will take place at the patient’s room in the ward to minimize the environment factor that may influence patient’s performance. Pre-assessment will be done one day before the intervention starts.

Participants in the control group will receive conventional chest physiotherapy. The estimated duration for control treatment is approximately around 30 minutes and is an individualised session. This treatment starts with participants will be seated upright with back supported. In this position, the participant performs deep breathing exercises, where inhalation through the nose and slow exhalation through the mouth, with 10 repetitions followed by 10 repetitions of active range of motion of both upper extremities. This treatment is included with combination of postural drainage, chest percussion and chest vibration with huffing and directed coughing to assist sputum expectoration. The treatment session will be carried out for four consecutive days, inpatient session, twice per day.

These intervention assessments are taken after completion of four days with twice sessions per day intervention course, consist of pain VAS scale, Modified BORG Dyspnea Scale, lung volumes and 6MWT.

The participants will be later followed up a month (4 weeks) post discharge via phone call. During the phone call, researcher will ask participants based on the St George’s respiratory questionnaire for COPD, Malaysian version (SQRQ- CM). The SQRQ-CM will evaluate (component) the QOL by the. St George’s respiratory questionnaire for COPD, Malaysian version (SQRQ- CM) was used for this study.
Control group
Active

Outcomes
Primary outcome [1] 338793 0
Pain
Timepoint [1] 338793 0
Baseline and four days following post intervention
Primary outcome [2] 338794 0
Dyspnea
Timepoint [2] 338794 0
Baseline and four days following post intervention
Primary outcome [3] 338795 0
Lung volumes
Timepoint [3] 338795 0
Baseline and four days following post intervention
Secondary outcome [1] 437489 0
Aerobic capacity
Timepoint [1] 437489 0
Baseline and four days following post intervention
Secondary outcome [2] 437490 0
Quality of life
Timepoint [2] 437490 0
During baseline and post one month ( 4 weeks ) after hospital discharge.

Eligibility
Key inclusion criteria
- Male and female patients age between 25 to 65 years old
- Diagnosed with acute exacerbation chronic obstructive pulmonary disorder
(AECOPD) GOLD 1-3
- Clinically stable state
- Able to understand simple Malay and English languages.
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Uncontrolled high blood pressure (Blood pressure of higher than 180/120 mmHg, or blood pressure of lower than 90/60 mmHg)
- Recent coronary artery diseases such as angina and congestive heart failure
- Orthopedic pathology of walking difficulties such as bone fractures, bone deformities
- Chronic respiratory failure of fully dependent on long term oxygen therapy such as
pulmonary embolism
- Cerebral difficulties/failures such as cerebral palsy, cerebral vascular accident

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software ( true random number generator (www.random.org) )
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori power analysis, a method that computes the required sample size based on a, power, and effect size, was used in this study. In accordance with a previous study by Mirza et al (2020), a Cohen's d of 0.731 was used for the effect size of FEV1, % predicted data, with power set at 0.8 and alpha at 0.05, to calculate the sample size. Considering a 20% drop-out rate, this study requires 31 participants for each group. Therefore, 62 participants are expected to be recruited.

All the data will be uniformly gathered and summarised. Statistical Package for Social Sciences (SPSS) 29.0 version will be used to analyse the data. The significance level is set to 0.05 to be considered as statistical significance. Descriptive statistics, including frequency counts for categorical variables and measurements of central tendency and dispersion for continuous variables (mean ± standard deviation, 95% confidence interval) will be calculated to outline the data. In the manner of non-normally distributed data, the continuous variables will be described by the median and interquartile range (IQR).

Shapiro-wilk test is used to determine the normality of data distribution. In the case of not normally distributed, Wilcoxon test was used for non-parametric data. In the evaluation of effectiveness of AD and walking exercise on pain scale, dyspnea level, lung volumes, aerobic capacity, and QOL among patients with AECOPD, paired t-test analysis was used when normal distribution is detected. For the comparison measurement data of baseline and post intervention of both experimental and control groups, paired sample t-test was utilised.

Thus, Levene test was used for parametric data, whereas Mann Whitney test was used for non-parametric data. Henceforth, descriptive analysis ( mean ± standard deviation) as used to measure the QOL of each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
1/02/2025
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment outside Australia
Country [1] 26420 0
Malaysia
State/province [1] 26420 0
Melaka

Funding & Sponsors
Funding source category [1] 316943 0
University
Name [1] 316943 0
National University of Malaysia
Country [1] 316943 0
Malaysia
Funding source category [2] 316944 0
Hospital
Name [2] 316944 0
Mahkota Medical Centre
Country [2] 316944 0
Malaysia
Primary sponsor type
University
Name
National University of Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 319189 0
None
Name [1] 319189 0
Address [1] 319189 0
Country [1] 319189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315695 0
UKM Research Ethics Committee (RECUKM)
Ethics committee address [1] 315695 0
Ethics committee country [1] 315695 0
Malaysia
Date submitted for ethics approval [1] 315695 0
15/06/2024
Approval date [1] 315695 0
27/06/2024
Ethics approval number [1] 315695 0
JEP-2024-445

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135530 0
Dr ASFARINA BINTI ZANUDIN
Address 135530 0
Centre for Rehabilitation and Special Needs Faculty of Health Sciences, Universiti Kebangsaan Malaysia Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur Malaysia
Country 135530 0
Malaysia
Phone 135530 0
+60392897354
Fax 135530 0
Email 135530 0
asfarina.zanudin@ukm.edu.my
Contact person for public queries
Name 135531 0
HANNAH BINTI HAFIZ
Address 135531 0
REHABILITATION DEPARTMENT, MAHKOTA MEDICAL CENTRE, NO 3, JALAN MERDEKA, TAMAN COSTA MAHKOTA, 75000 MELAKA
Country 135531 0
Malaysia
Phone 135531 0
+60196303737
Fax 135531 0
Email 135531 0
p131508@siswa.ukm.edu.my
Contact person for scientific queries
Name 135532 0
HANNAH BINTI HAFIZ
Address 135532 0
REHABILITATION DEPARTMENT, MAHKOTA MEDICAL CENTRE, NO 3, JALAN MERDEKA, TAMAN COSTA MAHKOTA, 75000 MELAKA
Country 135532 0
Malaysia
Phone 135532 0
+60196303737
Fax 135532 0
Email 135532 0
p131508@siswa.ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24048Ethical approval    388118-(Uploaded-28-07-2024-16-48-09)-JEP-2024-445.pdf



Results publications and other study-related documents

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