The effect of Pulmonary Rehabilitation on fracture risk of patients with Chronic Obstructive Pulmonary Disease.

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.