Study design and participants
The design was a randomized controlled pilot clinical trial.
One hundred people from Primary Healthcare Centers in Málaga begun this research and seventy-five subjects completed the study. The age of the participants of both genders ranged between 57 and 69.
Inclusion and exclusion criteria
The General Practitioner selected the participants who co-operated with the study. The criteria to be included in the study were inactive people, not engaged, with moderate physical activity for at least thirty minutes, five times a week . Participants also had to have three or more of the following cardiovascular risk factors: increased blood pressure 140/90, smoking, cholesterol above 230 mg / dl, a family member that had suffered a heart attack before the age of 55 if male or before the age of 65 if female and an obese or overweight (more than 8 kg) insulin-dependent diabetic .
The criteria to be excluded from participation in the study were the following: infectious processes, malignancy, metastasis, osteoporosis, inflammatory arthritis or fractures, cognitive impairment due to any cause .
The people who would participate in this study were randomized systematic procedures during the recruitment period. Random sequence generation was performed; people had to take a closed envelope from a box in order to form part of the intervention group or the control group. All the subjects who met the inclusion criteria had to carry out an initial evaluation before starting the procedure and at the end of twelve weeks the same procedure was carried out. The researcher, who did the evaluation, did not know what subjects would be assigned to each group.
Physical activity promotion programme (PAPP)
The intervention group (IG) performed a PAPP twice a week for twelve weeks, following the criteria of the American College of Sports Medicine  in the Sports and Physical Medical Center in Torremolinos. An assigned professional health specialist carried out the procedure between October and March of 2010 and 2011. Each session lasted 60 minutes, and all protocols were developed for progressive intensity, depending on each person. The sessions were organized at the early stage of heating, followed by the aerobic phase and the cooling-stretch or final phase.
Control group (CG)
The control group received an educational health leaflet containing advice from Primary Healthcare Centers in Málaga, and continued with their daily routine activities. Subjects were assessed on the outcome measures at baseline, at twelve weeks follow-up by an independent blind assessor, at the Sports and Physical Medical Center in Torremolinos, Spain.
The primary outcomes were the following: General Health Questionnaire determined with the Short Form-12 Health Survey (SF-12) and Health-related Quality of Life (HRQOL), determined with the EuroQoL-5D (EQ-5D).
The SF-12 questionnaire is a shortened version of the SF-36, and has a reliability coefficient of 0.97 . We report the results of eight general health dimensions: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role and mental health . These eight dimensions can also be used to generate both physical and mental health summary scores . The SF-12 questionnaire will prove to be a practical alternative to the SF-36, in order to measure the overall health of the population, because of the high degree of correspondence between estimated physical and mental health measures, using the SF-12 and SF-36 questionnaires .
The EQ-5D has five domains: mobility, self-care, usual activities, pain, and anxiety/depression . Each domain has three possible levels indicating; no problems, moderate problems or severe problems . The EQ-5D valuation questionnaire comprises a visual analogue scale which was not included in this research. It has shown to be a acceptable and valid tool, with an average estimation of 0.87 .
The secondary outcomes were cardiopulmonary. The cardiac outcomes were at resting heart rate, and achieved at the end of the test. Subjects were questionnaire about the rate perceived effort (RPE) several times during the exercise test . The pulmonary outcomes were the Tiffenau index, which is the ratio between forced expiratory volume in one second and forced vital capacity (FEV1/FVC), forced vital capacity (FVC) and forced expiratory volume in one second (FEV1). The values were expressed in absolute terms in milliliters and as percentage of theoretical value for individuals of the same age, weight and height in the reference population.
The exercise test
Subjects performed an exercise test on a treadmill according to the Bruce protocol . The sub maximal protocol was used for the exercise test in which the subject would be over 85% of the maximum frequency. The test was brought to an end when the subject reached the maximum achievable intensity, taking into account the following criteria: the theoretical maximum heart rate according to age, usually calculated as two hundred twenty minus age in years.
Participants were asked to identify their perception of perceived exertion every thirty seconds and end the test with the scale of effort adapted by Borg (RPE) from zero to ten points . The scale of the effort perception was defined as the subjective intensity of effort, stress, discomfort and / or fatigue you had felt during exercise .
The heart rate was measured at the beginning and at the end of the exercise test, which was called “HRf”, and was obtained at the end of the running test on the treadmill.
The simple spirometry was used to measure lung outcomes with pneumotachograph Fleisch DATOSPIR 120 according to the SEPAR’s criteria . Three maneuvers were performed in order to get only the best values for the analysis. The values are determined with forced vital capacity (FVC), forced expiratory volume in one second (FEV1), Tiffenau index which is the ratio between forced expiratory volume in one second and forced vital capacity (FEV1/FVC). The values are expressed in absolute terms in milliliters and as percentage of the theoretical value for individuals of the same age, weight and height in the reference population.
All participants received information about the research and gave their written consent before participation. We performed a general clinical interview which included an exercise test and a spirometry.
Data management and analysis
All analyses were conducted using SPSS version 17.0. Kolmogorov-Smirnov tests were used to analyze the normality of the data distribution. Student’s T tests for relational samples were performed to get the differences within each group after the intervention. We also used Student’s T test for independent samples to get the inter-group effect of this intervention.
The sample size was calculated with an alpha error of 0.05, a power of 0.80 and a beta risk of 0.20 according to the effect size of EQ-5D that it was made according to Cohen’s criteria . One hundred subjects took part in this research against 60 individuals are needed in a priori estimation: 30 individuals in the IG and 30 in the CG.
Evaluation of clinical relevance
Cohen’s criteria were taken into account in the analysis of the effect size values, his criteria determine that values below 0.2 are considered to have no effect, those between 0.2 and 0.5 a small effect, between 0.5 and 0.8 a medium effect, and those above 0.8 are considered to have a huge effect .
This study was authorized by the Ethics and Research Committee of the “Costa del Sol” Health District. All participants gave written informed consent, confidentiality and anonymity were also preserved at all times and the principles of the Declaration of Helsinki were respected.