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Trial registered on ANZCTR


Registration number
ACTRN12623001282673
Ethics application status
Approved
Date submitted
9/07/2023
Date registered
8/12/2023
Date last updated
8/12/2023
Date data sharing statement initially provided
8/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Pumonary Rehabilitation on fracture risk of patients with Chronic Obstructive Pulmonary Disease.
Scientific title
The effect of a Pulmonary Rehabilitation programme on 10-year risk of fragile fracture (FRAX score) in patients with COPD.
Secondary ID [1] 307531 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fragile Fractures 326966 0
Condition category
Condition code
Respiratory 324144 324144 0 0
Chronic obstructive pulmonary disease
Musculoskeletal 324145 324145 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will participate in a Pulmonary Rehabilitation program for COPD patients which includes physical exercise, dietary counselling, medical follow-up, education, behavioural therapy, respiratory physiotherapy and informative printed material. It well established that Pulmonary Rehabilitation programs restore physical condition, functional ability (6MWDT) (Spruit et al. 2013), health-related quality of life (SF-36, SGRQ) (Schroff et al. 2017). Pulmonary Rehabilitation in COPD also alleviates the symptoms of dyspnoea and fatigue (Borg scale) (Casaburi et al. 1991) and minimizes the future COPD exacerbations (1-year follow-up rehospitalizations) (Kjærgaard et al. 2020). In current trial is being evaluated the effect of Pulmonary Rehabilitation on 10-year possibility of fragile fractures to be happened (FRAX score).
The Pulmonary rehabilitation programme is located at Sotiria Hospital for Chest Diseases in Athens, Greece. The intervention group will enrol in the Rehabilitation Programme that the outpatient department of the same hospital runs. The intervention group will follow the programme for 13 weeks, 3 times per week and every session will last around 2 hours. A typical session will include: a) A face-to-face entry and a final medical evaluation (functional pulmonary testing, maximum exercise testing, 6MWDT) and weekly medical follow-up adjusting drug therapy (according GOLD guidelines) by the programme’s pulmonologist in cooperation with patients’ personal physician, b) Nurse face-to-face counselling for evaluation of disease’s symptoms (SpO2, Blood Pressure, Borg Scale measurements) and of the appropriate intake of therapy drugs (on site demonstration of the correct use of varying inhalers or nebulizers), c) The patients will be supervised by specialised respiratory physiotherapist of the hospital and will be trained in groups following individualised training programme which includes interval aerobic exercise session for 40 minutes at 100% of maximum work load (vigorous aerobic exercise), continuous submaximal aerobic exercise session on treadmill for 10-20 minutes at 3-4 dyspnoea Borg Scale and at 60% of maximum heart rate (moderate aerobic exercise), and resistance training at 60-120% of 1 repetition maximum (1-RPM) (moderate to vigorous anaerobic exercise), d) Respiratory Physiotherapy technics which include education of diaphragmatic breathing, pursed lips breathing, ergonomic technics and self-draining technics for bronchial secretions drainage will be implemented by the hospital physiotherapist for 15 minutes at the end of the whole session, e) A face-to-face dietary counselling by a specialist dietician of the hospital will take place once weekly and participants’ dietary habits will be evaluated (in the beginning the patients will record a one-week dietary calendar), their body composition will be analysed (using Bioelectrical Impedance Analysis) and will be proposed an individualised dietary programme on purpose of reversing cachexia or treating obese patients. The participants would learn to choose a balanced diet which do not stress the respiratory system by excessive metabolic CO2 production and they will be consulted to adopt long-term healthy habits. The program's nurse will also monitor the adherence to the program, keeping records of every patient attendance and checking if each patient will participate in every kind of intervention. For this reason, each patient will have a personal checklist where all the visits and activities will be thoroughly recorded.
A typical patient 65-year-old who will start the program, will be evaluated and examined by the program physician. As an example, the patient’s evaluation results are 100 watts in exercise testing, 250 meters in 6MWDT and FEV1 45%, in rest measurements Borg scale Dyspnoea=1, Fatigue=1, SpO2=95% and HR=80bpm, in maximum exercise testing the results are Borg Dyspnoea=8, Fatigue=8, HR=150bpm SpO2=88%. This patient will cycle for 40 min at 100 watts following interval mode (30 sec cycling/30 sec rest), they will walk for 20 min around 90-100 bpm and they should refer for both interventions Borg dyspnoea and fatigue 3-4 points. For quadriceps training for a given 1-RPM=10kgr they will exercise lifting weight from 6kgr in the beginning to 12kgr at the end of the program. Supplementary O2 will be administrated by nasal canula (2-4 lt/min) keeping SpO2 above 90%. If a drop in SpO2 below 90% may happen, the patient will take rest until the saturation will be again above 90%.
A printed informative material will be allocated to all participants, which inform them about COPD, the value of prophylactic measures (medical follow-up, regular exercise, vaccination, correct use of drug therapy, self-drainage technics). The material is belonged to the Hospital and has been constructed by the physician and the physiotherapist of the program according the guidelines of GOLD report and ATS/ERS official statement.
After programme’s completion the participants will follow a six-month post-rehabilitation supervised exercise programme twice weekly in different days from intervention program however with the same personnel. The three last months until the final measurements at 12-month time point the intervention group will follow the guidelines of informative material as the control group will do for the whole 12-month period.
Intervention code [1] 323992 0
Rehabilitation
Intervention code [2] 323993 0
Prevention
Comparator / control treatment
The Control group will accept the standard therapy for COPD according the specialist pulmonologist, which includes the drug therapy for COPD, regular follow up, consultancy and information about the disease (according latest GOLD report guidelines). Informative printed material (which is published by the hospital according GOLD, ATS/ERS guidelines) will also be provided to each patient from the control group with guidelines which the patients should follow until the final assessment will take place one year after the initial one. All the above will take place at outpatient’s respiratory department of Sotiria Hospital in Athens, Greece.
Control group
Active

Outcomes
Primary outcome [1] 333744 0
FRAX score, Fracture Risk Assessment Tool (Greek version).
Timepoint [1] 333744 0
Baseline, at the randomisation, and 12 months after the randomisation.
Primary outcome [2] 333745 0
Bone Mineral Density (BMD), dual-energy X-ray absorptiometry (DEXA).
Timepoint [2] 333745 0
Baseline, at the randomisation, and 12 months after the randomisation.
Primary outcome [3] 333746 0
Body Mass Index (BMI), participant’s weight in kilograms divided by the square of height in meters, assessed by a combo hospital manual weight scale with a stadiometer for height mesurements.
Timepoint [3] 333746 0
Baseline, at the randomisation, and 12 months after the randomisation.
Secondary outcome [1] 418131 0
Dysfunctional Breathing (Nijmegen score) will be assessed by Nijmegen Questionnaire (Greek version).
Timepoint [1] 418131 0
Baseline, at the randomisation, and 12 months after the randomisation.

Eligibility
Key inclusion criteria
Greek patients (male and female aged 55-80 years) with stable COPD stage I-VI from the region os Attica, Greece, who visit outpatient department of Sotiria Hospital of Chest Diseases in Athens, Greece.
Minimum age
55 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with the follow criteria will be excluded from the trial:
a) Anti-osteoporotic drug therapy up to three years before randomisation
b) Per os or intravenous corticosteroid therapy up to three months before randomisation
c) Charlson Comorbidity Index (CCI) >5
d) Thyroid disorders (untreated hyperthyroidism, over-treated hypothyroidism, primary hyperparathyroidism)
e) Excessive alcohol intake
f) Rheumatoid arthritis
g) Coeliac disease

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation of the patients in two groups will become with sealed envelopes (Thomas & Nelson, 1996). More specifically, for the given sample size of 24 participants (22 participants is the minimum sample size following our already done power analysis), there will be 12 sealed envelopes for control group and 12 for intervention’s group. The envelopes will be allocated in 6 mixed groups of 4 envelopes (2 for control and 2 for intervention). Each participant will be asked to choose one envelope from one group and following what is written inside (CONTROL or INTERVENTION) they will be randomised in two groups. The randomisation process will have been done by the beginning of study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The level of statistical significance is set at 0.05. The interaction between intervention (intervention group, control group) and time point (0, 12 months) for each variable (BMI, BMD, FRAX score, Nijmegen score) will be evaluated with 2x2 ANOVAs (ANOVA repeated measures) and Bonferroni correction. T-test parameters estimates will be carried out to evaluate differences between intervention and control group for each time point. The eta-squared will be used for the expression of the total variance explained by the interaction between intervention and time. The trend for each dependent variable will be calculated separately by orthogonal polynomial analysis for the two repeated measurements performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2024
Actual
Date of last participant enrolment
Anticipated
4/03/2024
Actual
Date of last data collection
Anticipated
3/03/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 25247 0
Greece
State/province [1] 25247 0
Athens/Attica

Funding & Sponsors
Funding source category [1] 311808 0
Self funded/Unfunded
Name [1] 311808 0
Andreas Daskalakis, PhD candidate/main researcher (own personal funds)
Country [1] 311808 0
Greece
Primary sponsor type
Individual
Name
Andreas Daskalakis
Address
Laboratory of Advanced Physiotherapy (LAbPhys),Physiotherapy Department, University of West Attica (UNIWA),28 Ag. Spyridonos, Aigaleo, 12243,Athens, Greece.
Country
Greece
Secondary sponsor category [1] 313283 0
Individual
Name [1] 313283 0
Eirini Grammatopoulou
Address [1] 313283 0
Physiotherapy Department, University of West Attica (UNIWA),28 Ag. Spyridonos, Aigaleo, 12243,Athens, Greece.
Country [1] 313283 0
Greece
Other collaborator category [1] 282543 0
Hospital
Name [1] 282543 0
General Hospital of Chest Diseases "Sotiria"
Address [1] 282543 0
152 Mesogeion, Athens 115 27.
Country [1] 282543 0
Greece
Other collaborator category [2] 282544 0
University
Name [2] 282544 0
University of West Attica, Department of Physiotherapy
Address [2] 282544 0
28 Ag. Spyridonos, Aigaleo, 12243.
Country [2] 282544 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311252 0
Ethics Committee of the University of West Attica in Greece.
Ethics committee address [1] 311252 0
University of West Attica (UNIWA),28 Ag. Spyridonos, Aigaleo, 12243,Athens
Ethics committee country [1] 311252 0
Greece
Date submitted for ethics approval [1] 311252 0
26/03/2021
Approval date [1] 311252 0
05/04/2021
Ethics approval number [1] 311252 0

Summary
Brief summary
The purpose of this study is to evaluate the effect of a Pulmonary Rehabilitation programme on 10-year risk of bone fracture in COPD patients. A group of COPD patients will undergo a rehabilitation program, which includes exercise, physiotherapy, medical and dietary consultation for 13 week and they will be evaluated at the beginning of the program and one year after however the rehab program plays a protective role on osteoporotic bone fractures. The Rehabilitation program may have a positive effect on bone fractures decreasing the 10-year risk of them to may be happened.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120466 0
Mr Andreas Daskalakis
Address 120466 0
Laboratory of Advanced Physiotherapy (LAbPhys),Physiotherapy Department, University of West Attica (UNIWA),28 Ag. Spyridonos, Aigaleo, 12243,Athens, Greece.
Country 120466 0
Greece
Phone 120466 0
+306974311945
Fax 120466 0
Email 120466 0
adaskalakis@uniwa.gr
Contact person for public queries
Name 120467 0
Mr Andreas Daskalakis
Address 120467 0
Laboratory of Advanced Physiotherapy (LAbPhys),Physiotherapy Department, University of West Attica (UNIWA),28 Ag. Spyridonos, Aigaleo, 12243,Athens, Greece.
Country 120467 0
Greece
Phone 120467 0
+306974311945
Fax 120467 0
Email 120467 0
adaskalakis@uniwa.gr
Contact person for scientific queries
Name 120468 0
Mr Andreas Daskalakis
Address 120468 0
Laboratory of Advanced Physiotherapy (LAbPhys),Physiotherapy Department, University of West Attica (UNIWA),28 Ag. Spyridonos, Aigaleo, 12243,Athens, Greece.
Country 120468 0
Greece
Phone 120468 0
+306974311945
Fax 120468 0
Email 120468 0
adaskalakis@uniwa.gr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Because of the REGULATION (EU) 2016/679


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18258Ethical approval    384352-(Uploaded-07-02-2023-03-07-34)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18258Ethical approval    384352-(Uploaded-07-02-2023-03-07-34)-Study-related document.pdf
23878Ethical approval    384352-(Uploaded-11-06-2024-20-18-29)-Ethics Comitee UniWA.el.en.pdf

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.