Contact information
Type
Scientific
Primary contact
Dr Concepción Larraz
ORCID ID
Contact details
Reina Esclaramunda 9
Palma de Mallorca
07003
Spain
clarraz@ibsalut.caib.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Marató TV3 PI04/2610
Study information
Scientific title
A 3-arm randomised controlled parallel group trial to determine the efficacy of pulmonary rehabilitation in moderate Chronic Obstructive Pulmonary Disease (COPD) patients in primary health care and maintenance of benefits at 2 years
Acronym
REHPOCAP
Study hypothesis
1. In patients with COPD, a long term (24 months) programme of pulmonary rehabilitation will improve the quality of life compared with patients that follow a short term duration (12 weeks) programme of pulmonary rehabilitation and compared with those who follow usual care
2. Patients included in the long term programme have less exacerbations for COPD, and a decreased number of hospital admission and inpatient stays in hospitals compared with patients with a short duration pulmonary rehabilitation programme and compared with those patients who follow usual care.
3. Patients involved in a short term pulmonary rehabilitation programme (12 weeks) improve the parameters mentioned above but the improvement is not maintained at 24 months.
Ethics approval
The trial obtained approval from the Majorca Primary Care Research Committee and from the regional Ethical Committee of Clinical Research (ref: IB370/04 PI)
Study design
Randomised three arm blinded parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a pulmonary rehabilitation booklet or patient information sheet (in Spanish).
Condition
Chronic Obstructive Pulmonary Disease
Intervention
Patients in the two intervention groups will receive a pulmonary rehabilitation programme of three, 90 minutes weekly sessions during 12 weeks. The sessions consist of four types of interventions:
1. Educative sessions on anatomy and physiology of respiratory system, correct use of inhalators and a brief counselling to stop smoking. This action will be carried out in weeks 1, 6 and 12.
2. Respiratory Physiotherapy (self conscious breathing control, diaphragmatic breathing control, chest wall exercises, and abdominal muscles wall work) during weeks 1, 6 and 12.
3. Low intensity peripheral muscle training. It consists on abdominal and upper and lower limbs exercises, shoulder and arms circling, raising weights and other exercises. The program has been described by (Clark CJ 1996) and has been used in other clinical trials (Normandin EA 2002, Foglio K 1999). Each exercise is repeated between 8-10 times during 45 minutes. It takes one and half hours to complete exercise with small breaks. The program has 12 weeks duration.
4. Patients will be asked to practice a low level home-based exercise program adapted to individual characteristics. Compliance with home-based programme will be assessed every two weeks with the patient and registered in a spread-sheet. Interventions will be carried out in groups of 8-10 persons. A primary care nurse will carry out the educative intervention and the exercises programme by two physiotherapists in two Primary Care Physiotherapy Units. Nurses will be trained in the educative intervention and group dynamic. In order to standarise physiotherapist intervention, a 7 days tuition programme will be developed.
5. After completing the 12 weeks pulmonary rehabilitation programme, each patient will be included in the activities of the initially assigned group RHBM, or RHB.
5.1. patients in group RHB will follow their usual care with his physician and nurse.
5.2. patients in group RHBM will follow a weekly session of maintenance till the end of the programme at 24 months.
5.3. patients in control group will follow their usual care with their physician and nurse from the inception.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Quality of life:
Assessed by the Spanish validated version of the Chronic Respiratory Questionnaire (CRQ) a 20 items scale, administered by an interviewer, designed for COPD patients. Each item is graded on 7-point likert scale. It includes four domains: dyspnoea (5 items), fatigue (4 items), emotional function (7 items) and mastery (4 items). It scores each dimension summing the punctuation of each item or through items average. The clinical repercussion of changes in the punctuation of CRQ after a therapeutic intervention (minimal important difference - MDCI) is 0.5 per item and 10 global scoring, a change of 2.5 in dyspnoea domain, 2 for fatigue and mastery and 3.5 for emotional function (Reardon J 1994). The questionnaire was adapted and validated by Güell et al (Güell R et al. Eur Respir J 1998; 11: 55-60.), showing good psychometric properties, high reliability and sensitivity to changes.
Secondary outcome measures
1. The 6-min-walking test:
Conducted along a flat corridor during 25 minutes. Each patient will be instructed and receive standarised encouragement to walk from one end to the other, covering as much ground as possible during the allotted time, as recomended by the American Thoracic Society.
2. Patients will rate their level of dyspnoea in daily activities through the Dyspnoea Index (Borg scale):
A 10cm visual analogue scale bounded by the descriptors 'no shortness of breath at all' and 'maximum shortness of breath' and using the Medical Research Council (MRC) scale which specifies eight levels of dyspnoea.
3. Lung function testing:
Including forced spirometry with bronchodilator test with a Datospir 120 spirometer following Spanish Society of Pneumology and Thoracic Surgery (SEPAR) recommendations for the values of FVC, FEV1, FEV1/FVC and Finite Element Model (FEM).
4. Number of hospital admissions and length of stay:
By patient information. This information will be validated through hospital medical records.
5. Number of severe exacerbations:
Defined as episodes of either dyspnoea or dry or productive cough, whether sputum was purulent or not, treated with oral corticoids and/or antibiotics requiring hospital admission.
Overall trial start date
10/03/2004
Overall trial end date
15/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Clinical diagnosis of COPD with values of forced spirometry after broncodilatation of the ratio Forced Expiration Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) less than 0.7 and FEV1 between 30% and 80% of its reference values (Global Initiative for Chronic Obstructive Lung Disease [GOLD] criteria of moderate COPD).
2. Age between 35 and 74 years old.
3. No experience of exacerbation or hospital admission in the month before inclusion.
4. Willingness to participate in the study and signed informed consent.
Smoking will not be considered as an exclusion criterion.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
97
Participant exclusion criteria
1. Patients with severe and very mild COPD
2. FEV1<30% and >80%
3. Relevant osteoarticular disease or other debilitating diseases that could affect normal ambulation
4. Other important diseases that can impede follow-up (terminal patients, inmunodeficiencies, chronic infections)
5. Ischaemic heart disease, clinically evident, severe or uncontrolled systemic arterial hypertension.
Recruitment start date
10/03/2004
Recruitment end date
15/06/2008
Locations
Countries of recruitment
Spain
Trial participating centre
Reina Esclaramunda 9
Palma de Mallorca
07003
Spain
Sponsor information
Organisation
TV3 Marathon Foundation (Fundació La Marató de TV3) (Spain)
Sponsor details
Ganduxer 117
Barcelona
08022
Spain
aferrer.t@ccma.cat
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
TV3 2004 Marathon Foundation (Fundació Marató TV3 2004) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16978561 (in Spanish)
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23399113
Publication citations
-
Results
Román M, Larraz C, Gómez A, Ripoll J, Mir I, Miranda EZ, Macho A, Thomas V, Esteva M, Efficacy of pulmonary rehabilitation in patients with moderate chronic obstructive pulmonary disease: a randomized controlled trial., BMC Fam Pract, 2013, 14, 21, doi: 10.1186/1471-2296-14-21.
-
Gómez A, Román M, Larraz C, Esteva M, Mir I, Thomás V, Ripio J, Miranda Pacheco EZ, Macho A, [Efficacy of respiratory rehabilitation on patients with moderate COPD in primary care and maintenance of benefits at 2 years]., Aten Primaria, 2006, 38, 4, 230-233.