Chronic Obstructive Pulmonary Disease Clinical Trial
— PAEPOfficial title:
The Efficacy of a Physical Activity Enhancing Programme Using Activity Monitors With Set Targets and Feedback for Enhancing Physical Activity Levels in Patients With COPD Attending Pulmonary Rehabilitation.
Verified date | April 2017 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with Chronic Obstructive Pulmonary Disease are characterised by a sedentary lifestyle. This contributes to increase the number of hospitalizations and mortality. Changing this lifestyle is a major objective of the management of these patients. Pulmonary rehabilitation helps patients to increase their fitness, but modifying a longstanding sedentary habit is more difficult to achieve. This project aims at modifying patients' long term physical activity with a physical activity coaching programme. This will help patients to transform the benefits of pulmonary rehabilitation into a healthier active lifestyle and contribute to reduce hospitalizations, increase quality of life and survival.
Status | Completed |
Enrollment | 46 |
Est. completion date | March 30, 2017 |
Est. primary completion date | March 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 95 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2013) referred for pulmonary rehabilitation; - Clinical stability concerning pulmonary infections or acute exacerbations within last four weeks; - Absence of recent Myocardial Infarction (within last 3 months), unstable angina, other significant cardiac problems, SBP > 180 mmHg, DBP > 100 mmHg or tachycardia (higher than 100 bpm); - Absence of significant orthopaedic, neurological, cognitive and/or psychiatric impairment restricting mobility; - Not following any exercise programme in the last 6 months. Exclusion Criteria: - Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator; - Respiratory diseases other than COPD (e.g. asthma); - COPD exacerbations within 4 weeks prior to Visit 1; - Cognitive impairment and inability to give informed consent, as judged by the investigator; - Involvement in the planning and/or conduct of the study; - Participants should not be taking part in any other studies. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Physiotherapy Department - Leith Community Treatment Centre | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | Philips Healthcare |
United Kingdom,
Breyer MK, Breyer-Kohansal R, Funk GC, Dornhofer N, Spruit MA, Wouters EF, Burghuber OC, Hartl S. Nordic walking improves daily physical activities in COPD: a randomised controlled trial. Respir Res. 2010 Aug 22;11:112. doi: 10.1186/1465-9921-11-112. — View Citation
de Blok BM, de Greef MH, ten Hacken NH, Sprenger SR, Postema K, Wempe JB. The effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation in patients with COPD: a pilot study. Patient Educ Couns. 2006 Apr;61(1):48-55. Epub 2006 Feb 7. — View Citation
Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Antó JM. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax. 2006 Sep;61(9):772-8. Epub 2006 May 31. — View Citation
Nici L, Donner C, Wouters E, Zuwallack R, Ambrosino N, Bourbeau J, Carone M, Celli B, Engelen M, Fahy B, Garvey C, Goldstein R, Gosselink R, Lareau S, MacIntyre N, Maltais F, Morgan M, O'Donnell D, Prefault C, Reardon J, Rochester C, Schols A, Singh S, Troosters T; ATS/ERS Pulmonary Rehabilitation Writing Committee.. American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1390-413. — View Citation
Pitta F, Troosters T, Probst VS, Langer D, Decramer M, Gosselink R. Are patients with COPD more active after pulmonary rehabilitation? Chest. 2008 Aug;134(2):273-80. doi: 10.1378/chest.07-2655. Epub 2008 Apr 10. — View Citation
Pitta F, Troosters T, Spruit MA, Probst VS, Decramer M, Gosselink R. Characteristics of physical activities in daily life in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 1;171(9):972-7. Epub 2005 Jan 21. — View Citation
Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium.. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8. — View Citation
Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Physical Activity in Daily Life (PADL) levels at 12 weeks. | The assessment of physical activity in daily life will be conducted with a validated activity monitor to assess physical activity levels (PAL) in patients with COPD, the triaxial Actigraph GT3x accelerometer. This is a small (4.6cm x 3.3cm x 1.5cm), lightweight (19 grams) and portable device that is worn around the hip to assess movement and provide several outputs reflecting PADL (i.e. raw acceleration, energy expenditure, MET rates, steps taken, physical activity intensity, subject position) by its triaxial sensor, tracking the body motion every time subjects move up, down, forwards, backwards and sideways. By measuring the acceleration of these movements, it calculates how much energy subjects used to make them. The device will be used by the patients for at least 10 hours/day during the evaluation period of one week simultaneously with the baseline assessment of PAL conducted by the DirectLife. | 12 weeks | |
Primary | Change from Baseline in Physical Activity in Daily Life (PADL) levels at 24 weeks. | The assessment of physical activity in daily life will be conducted with a validated activity monitor to assess physical activity levels (PAL) in patients with COPD, the triaxial Actigraph GT3x accelerometer. This is a small (4.6cm x 3.3cm x 1.5cm), lightweight (19 grams) and portable device that is worn around the hip to assess movement and provide several outputs reflecting PADL (i.e. raw acceleration, energy expenditure, MET rates, steps taken, physical activity intensity, subject position) by its triaxial sensor, tracking the body motion every time subjects move up, down, forwards, backwards and sideways. By measuring the acceleration of these movements, it calculates how much energy subjects used to make them. The device will be used by the patients for at least 10 hours/day during the evaluation period of one week simultaneously with the baseline assessment of PAL conducted by the DirectLife. | 24 weeks | |
Secondary | Change from Baseline in Exercise Capacity at 12 weeks. | A constant work rate test, the Endurance Shuttle Walking Test (ESWT), will be performed following an incremental shuttle walking test (ISWT). The later will assess the maximal exercise capacity of the patient and help to calculate the submaximal load (75% of the maximal load) used during the ESWT. | 12 weeks | |
Secondary | Change from Baseline in Exercise Capacity at 24 weeks. | A constant work rate test, the Endurance Shuttle Walking Test (ESWT), will be performed following an incremental shuttle walking test (ISWT). The later will assess the maximal exercise capacity of the patient and help to calculate the submaximal load (75% of the maximal load) used during the ESWT. | 24 weeks | |
Secondary | Change from Baseline in Peripheral Muscle Strength at 12 weeks. | The quadriceps maximal voluntary contraction test (QMVC) will be performed using an isokinetic machine. Patients will be sitting on a chair specifically designed to measure leg strength. Their dominant leg will be attached to a lever that will record the strength that they will produce. The test consists in measuring the strength of patients' leg applied against a steady lever. Patients will be encouraged to perform at least 3 sustained maximal knee extension of between 5 and 10 seconds duration. There will be a gap of 30-60 seconds between each contraction to allow time to recover from each effort. In order to assess peripheral muscle fatigue, patients will undertake a 30-repetition quadriceps contraction test using the same isokinetic machine. The test consists of 30 consecutive quadriceps contractions at 70% of patients' maximal voluntary contraction. All measures are very simple to perform and will be conducted after patients get familiar with the machine and the techniques. |
12 weeks | |
Secondary | Change from Baseline in Peripheral Muscle Strength at 24 weeks. | The quadriceps maximal voluntary contraction test (QMVC) will be performed using an isokinetic machine. Patients will be sitting on a chair specifically designed to measure leg strength. Their dominant leg will be attached to a lever that will record the strength that they will produce. The test consists in measuring the strength of patients' leg applied against a steady lever. Patients will be encouraged to perform at least 3 sustained maximal knee extension of between 5 and 10 seconds duration. There will be a gap of 30-60 seconds between each contraction to allow time to recover from each effort. In order to assess peripheral muscle fatigue, patients will undertake a 30-repetition quadriceps contraction test using the same isokinetic machine. The test consists of 30 consecutive quadriceps contractions at 70% of patients' maximal voluntary contraction. All measures are very simple to perform and will be conducted after patients get familiar with the machine and the techniques. |
24 weeks | |
Secondary | Change from Baseline in Health Related Quality of Life (HRQoL) at 12 weeks. | The Chronic Respiratory Questionnaire (CRQ), a specific questionnaire for patients with COPD will be applied for the assessment of the quality of life. The COPD assessment test (CAT) will also be used. | 12 weeks | |
Secondary | Change from Baseline in Health Related Quality of Life (HRQoL) at 24 weeks. | The Chronic Respiratory Questionnaire (CRQ), a specific questionnaire for patients with COPD will be applied for the assessment of the quality of life. The COPD assessment test (CAT) will also be used. | 24 weeks | |
Secondary | Change from Baseline in Acute Exacerbation rate at 12 weeks. | Data on exacerbations that required antibiotics and/or oral corticosteroid will be recorded by asking the patients about acute exacerbations of the disease in the previous years/weeks. | 12 weeks. | |
Secondary | Change from Baseline in Acute Exacerbations rate at 24 weeks. | Data on exacerbations that required antibiotics and/or oral corticosteroid will be recorded by asking the patients about acute exacerbations of the disease in the previous years/weeks. | 24 weeks. | |
Secondary | Change from Baseline in Degree of Dyspnoea at 12 weeks. | The Medical Research Council Scale (MRC) will be used to evaluate the sensation of dyspnoea during daily living activities. | 12 weeks | |
Secondary | Change from Baseline in Degree of Dyspnoea at 24 weeks. | The Medical Research Council Scale (MRC) will be used to evaluate the sensation of dyspnoea during daily living activities. | 24 weeks | |
Secondary | Change from Baseline in Anxiety and Depression levels at 12 weeks. | Levels of anxiety and depression will be measured by the Hospital Anxiety and Depression Scale (HADS). | 12 weeks | |
Secondary | Change from Baseline in Anxiety and Depression levels at 24 weeks. | Levels of anxiety and depression will be measured by the Hospital Anxiety and Depression Scale (HADS). | 24 weeks | |
Secondary | Change from Baseline in psychological status at 12 weeks | A number of psychological constructs will be measured using a number or different (validated) questionnaires. The constructs we are measuring are: Coping with problems¬, positive health (psychosocial wellbeing), social support, self-efficacy, affect, and motivation. | 12 weeks | |
Secondary | Change from Baseline in psychological status at 24 weeks | A number of psychological constructs will be measured using a number or different (validated) questionnaires. The constructs we are measuring are: Coping with problems¬, positive health (psychosocial wellbeing), social support, self-efficacy, affect, and motivation. | 24 weeks | |
Secondary | Change from Baseline in Systemic inflammation at 12 weeks | Levels of systemic inflammation (White blood cells, serum C-reactive protein and circulating cytokines) will be assessed in blood samples. Twenty milliliters (20 ml) of blood will be obtained in a serum tube (brown). Spin at 1200 rpm. Serum aliquot and stored at -80 degree. Samples will be identified with the date and the patients' study id (anonymised id). Serum C-reactive protein (CRP) concentrations will be measured using a highly sensitive immunonephelometric assay. Serum cytokine assessment will be carried out using Cytometric Bead Array (CBA) for simultaneous detection of ten cytokines in serum. | 12 weeks |
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