ANZCTR - Registration

Registration number

ACTRN12624000988550

Ethics application status

Approved

Date submitted

12/07/2024

Date registered

13/08/2024

Date last updated

13/08/2024

Date data sharing statement initially provided

13/08/2024

Type of registration

Retrospectively 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]

NIL KNOWN

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

AECOPD

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Physical Medicine / Rehabilitation

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.
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, back and forth, 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]

Rehabilitation

Intervention code [2]

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.

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. Subsequently, the exercises also included 5 repetitions of huffing and coughing for 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]

Pain

Timepoint [1]

Baseline and four days following post intervention

Primary outcome [2]

Dyspnea

Timepoint [2]

Baseline and four days following post intervention

Primary outcome [3]

Lung volumes

Timepoint [3]

Baseline and four days following post intervention

Secondary outcome [1]

Aerobic capacity

Timepoint [1]

Baseline and four days following post intervention

Secondary outcome [2]

Quality of life

Timepoint [2]

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
- Cognitively compliant or mentally stable
- 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)
- 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

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. This study will utilise to treat intention analysis. 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

Recruiting

Date of first participant enrolment

Anticipated

Actual

3/07/2024

Date of last participant enrolment

Anticipated

3/09/2024

Actual

Date of last data collection

Anticipated

10/10/2024

Actual

Sample size

Target

62

Accrual to date

10

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Melaka

Funding & Sponsors

Funding source category [1]

University

Name [1]

National University of Malaysia

Country [1]

Malaysia

Funding source category [2]

Hospital

Name [2]

Mahkota Medical Centre

Country [2]

Malaysia

Primary sponsor type

University

Name

National University of Malaysia

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UKM Research Ethics Committee (RECUKM)

Ethics committee address [1]

+60391455046/5048

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

15/06/2024

Approval date [1]

27/06/2024

Ethics approval number [1]

JEP-2024-445

Summary

Brief summary

The purpose of this intervention randomised controlled trial study is to investigate the effectiveness of autogenic drainage and walking exercise on pain scale, dyspnea level, lung volumes, aerobic capacity and quality of life of patients with AECOPD. A total of 62 inpatient AECOPD will randomly divide into experimental (n=31) and control (n=31) group. The experimental group received AD and walking exercise whereas control group receive conventional chest physiotherapy. Treatment will be conducted for four consecutive days, two sessions per day. Post one month hospitalization later was to follow up for QOL. Primary outcome will be the VAS pain scale, Modified Borg Dyspnea scale, lung volumes and six-minute walk test (6MWT) and assess at baseline and post intervention. Secondary outcome is St George’s respiratory questionnaire for COPD, Malaysian version (SQRQ- CM). Treatment outcomes will be evaluated on the last day of intervention and post one month follow-up.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr ASFARINA BINTI ZANUDIN

Address

Centre for Rehabilitation and Special Needs Faculty of Health Sciences, Universiti Kebangsaan Malaysia Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur Malaysia

Country

Malaysia

Phone

+60392897354

Email

[email protected]

Contact person for public queries

Name

HANNAH BINTI HAFIZ

Address

REHABILITATION DEPARTMENT, MAHKOTA MEDICAL CENTRE, NO 3, JALAN MERDEKA, TAMAN COSTA MAHKOTA, 75000 MELAKA

Country

Malaysia

Phone

+60196303737

Email

[email protected]

Contact person for scientific queries

Name

HANNAH BINTI HAFIZ

Address

REHABILITATION DEPARTMENT, MAHKOTA MEDICAL CENTRE, NO 3, JALAN MERDEKA, TAMAN COSTA MAHKOTA, 75000 MELAKA

Country

Malaysia

Phone

+60196303737

Email

[email protected]

Trial Review

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Documents added automatically