Asthma
Conditions
Keywords
Asthma, Physical Therapy, Modalities, Physical Therapy, Speciality, Nordic Walking, Patient Education as Topic, Walk Test, Randomized Controlled Trial
Brief summary
A parallel group, randomized controlled trial to compare the effectiveness of an eight-week Nordic walking program plus three educational sessions and usual care in contrast to three educational sessions and usual care in patients with asthma. The researchers hypothesize that Nordic walking program plus educational sessions and usual care is superior to educational sessions and usual care in terms of exercise tolerance, physical activity, asthma and symptoms control, dyspnea, lung function, handgrip strength, quality of life, quality of sleep, rate of medication intake, treatment adherence, and healthcare use in patients with asthma
Detailed description
Sample size was calculated considering a minimum clinically important difference (MCID) of 26 meters and a standard deviation of 45.49 meters. With a power of 80%, an alpha level of 0.05 and supposing a dropout rate of 15%, a total of 114 patients, 57 in each group, are required. Patients will be recruited from Pulmonology and Allergology services of University Hospital Complex of A Coruña, Pulmonology service of HM Modelo Hospital (A Coruña) and primary care centres in Coruña. Nordic walking and educational sessions will be conducted in A Coruña city. Exercise tolerance, physical activity, asthma and symptoms control, dyspnea, lung function, handgrip strength, quality of life, quality of sleep, rate of medication intake, treatment adherence, and healthcare use will be measured at baseline, and then at two (post-intervention), three and six months. Respiratory muscle strength will be measure at baseline to characterize the sample. Any adverse effect occurring during evaluation or intervention will be recorded and analysed. Data distribution will be check with Kolmogorov-Smirnov test. Quantitative data will be expressed as mean and standard deviation when normally distributed and as a median and quartiles (Q1-Q3) when no normally distributed. To compare outcomes between Nordic walking group (NWG) and control group (CG), it will be calculated an ANOVA test for repeated measures or a Kruskal-Wallis test. Also, qualitative analysis will be made to get information about NWG experience: the way to deal with the disease, satisfaction with the intervention given, perceived progress in management of disease after intervention. Qualitative information will be collected from focus groups. The interview will be recorded, transcript, and re-read by two of the investigators to generate codes and, afterwards, themes. These themes will be named and defined. Absolut and relative frequencies will be analysed from each theme. Inter-rate agreement will be measured through agreement percentages calculated as number of thematic units in which evaluators agree divided by total number of units; and through Kappa of Cohen, considering \>0.81 almost a perfect agreement.
Interventions
PROCEDURENordic walking program
Nordic walking program will consist of three training sessions per week, during eight weeks. Each session will last approximately 60 minutes, including warm-up, the intervention itself and cool-down. Intervention will consist in a 30 minutes Nordic walking, working at 70-85% of maximal heart rate, measured with a Polar pulsometer. Intervention will be delivered in groups (six patients per group as maximum), in designed circuits placed in A Coruña city.
PROCEDUREEducational sessions and usual care
Educational sessions will consist in three classes, about 60 minutes each. In these classes, participants will learn about their pulmonary system, asthma disease, asthma diagnosis, asthma classification, asthma exacerbations and triggers, types of medications, how to take inhalers, how to measure PEF (peak expiratory flow), how to control the environment in order to prevent exacerbations, healthy-lifestyle recommendations and the importance of an active lifestyle, what to do in case of asthma emergency, and how to do required data from patients to note in their Patient's Diary (one of the evaluation tools). Usual care implies following the current therapeutic plan and revisions planned by their specialist/GP.
Sponsors
Sociedad Española de Neumología y Cirugía Torácica (SEPAR), Spain
Colexio Oficial de Fisioterapeutas de Galicia (COFIGA), Spain
Universidade da Coruña
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Only investigator making evaluation is blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being ≥18 years old. * Present an asthma diagnosis. * People that desires participate in the study. * People able to sign the informed consent.
Exclusion criteria
* People with other respiratory pathologies. * Smokers. * Asthma exacerbation in the last four weeks. * Heart failure in the last six months. * Cardiac arrhythmia with IIIb or superior grade in Lown scale. * Respiratory infection in the last four weeks. * Gait disorders that impaired the Nordic walking activity. * Comorbidities that entail reduced exercise capacity: significant anaemia, electrolyte imbalance, or hyperthyroidism. * People that follow training sessions of more than 30 minutes per day with a moderate or vigorous intensity. * People that have followed in last three months a pulmonary rehabilitation program. * Pregnant and lactating women. * People meeting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute walk test (6MWT) distance | At baseline, and at two (post-intervention), three and six months. | Change in the 6MWT distance. The 6MWT will be performed according to the American Thoracic Society / European Respiratory Society recommendations (ATS/ERS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function | At baseline, and at two (post-intervention), three and six months. | Forced spirometry (Datospir® 120C, Sibelmed, Barcelona, Spain): to analyse changes in forced expiratory volume in first second (FEV1), forced vital capacity (FVC), FEV1/FVC. Following international recommendations of American Thoracic Society / European Respiratory Society (ATS/ERS). |
| Health Related Quality of Life | At baseline, and at two (post-intervention), three and six months. | Change in EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire results, validated in people with asthma and in Spanish population. Each dimension can be scored from level 1 (no problems in a specific dimension) to level 5 (extreme problems in a specific dimension). |
| Qualitative changes in the physical activity done in patient's daily life. | At two months after baseline measures (post-intervention), at three and six months. | Changes in physical activity registered by patients in their Patient's Diary will be analysed. |
| Qualitative changes in self-perception of mood in patient's daily life. | At two months after baseline measures (post-intervention), at three and six months. | Changes in self-perception of mood registered by patients in their Patient's Diary will be analysed. |
| Quality of sleep | At baseline, and at two (post-intervention), three and six months. | Change in Pittsburgh Quality Sleep Index (PQSI) results, validated in Spanish population. The PSQI global score has a possible range of 0 to 21 points, being 0 the best score. |
| Medication adherence and recommendations compliance | At two months after baseline measures (post-intervention), three and six months. | Adherence will be assessed by analysing different items that the participants should note in their Patients's Diary, in order to determine the treatment and recommendations compliance. |
| Number of repetitions in the one-minute sit to stand test (1MSTST) | At baseline, and at two (post-intervention), three and six months. | Change in number of repetitions of 1MSTST. |
| Number of steps per day | At baseline, and at two (post-intervention), three and six months. | Change in number of steps per day measured by accelerometry with DynaPort ® MM+. |
| Average of steps per week | At two months after baseline measures (post-intervention), at three and six months. | Analysed through Patient's Diary, in where they must register daily number of steps walked. |
| Time lying down | At baseline, and at two (post-intervention), three and six months. | Change in time lying down measured by accelerometry with DynaPort® MM+. |
| Time sitting | At baseline, and at two (post-intervention), three and six months. | Change in time sitting measured by accelerometry with DynaPort® MM+. |
| Time standing up | At baseline, and at two (post-intervention), three and six months. | Change in time standing up measured by accelerometry with DynaPort® MM+. |
| Time walking | At baseline, and at two (post-intervention), three and six months. | Change in time walking measured by accelerometry with DynaPort® MM+. |
| Kilocalories consumed | At baseline, and at two (post-intervention), three and six months. | Change in kilocalories consumed measured by accelerometry with DynaPort ® MM+. |
| Metabolic equivalent of task (MET) consumed | At baseline, and at two (post-intervention), three and six months. | Change in MET consumed measured by accelerometry with DynaPort ® MM+ and International Physical Acitvity Questionnaire, short form (IPAQ). |
| Level of physical activity | At baseline, and at two (post-intervention), three and six months. | Change in category level of physical activity (low (worst level of physical activity), moderate or high) in function of MET-minutes/week, measured by International Physical Activity Questionnaire, a cualitative and quantitative scale. |
| Asthma-related symptoms and asthma control | At baseline, and at two (post-intervention), three and six months. | Change in Control of Allergic Rhinitis and Asthma Test (CARAT) results, validated in patients with asthma and in Spanish population. The range of possible scores is 0-30, being 0 the complete absence of control. |
| Dyspnea | At baseline, and at two (post-intervention), three and six months. | Change in dyspnea measured with Modified Medical Research Council scale (mMRC). Scores range from 0 to 4, being 0 the best punctuation. |
| Handgrip Strength | At baseline, and at two (post-intervention), three and six months. | Change in handgrip strength measured through handgrip dynamometry with Jamar® Hydraulic Hand dynamometer (Performance Health, Warrenville, IL, USA), following the international recommendations (Mathiowetz et al., 1985). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Muscle Strength | At baseline | Maximal inspiratory pressure (PImax) and maximal expiratory pressure (PEmax) will be measured following recommendations of Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) using a digital manometer MicroRPM® (Vyaire Medical GmbH, Hoechberg, Germany), and PUMA® software (Vyaire Medical GmbH, Hoechberg, Germany). No change is expected, so the measure will be only assessed at baseline in order to characterize the sample. |
| Adverse effects | During intervention, at two months after baseline measures (post-intervention), three and six months. | Any inconvenience related with intervention, or affecting it, will be registered. |
| Satisfaction of Nordic walking group with intervention given | At two months after baseline measures (post-intervention). | It will be assessed with a group interview through focus groups only in Nordic walking intervention group. The interview will be made following a semi structured guide with open-ended questions to try to aboard: the way of affront their disease; experience and satisfaction with the intervention given (facilitators and barriers to their participation) and perceived improvement in asthma management after intervention. |
| Health care use | At two months after baseline measures (post-intervention), at three and six months. | Information noted by patients in their Patient's diary, relative to unscheduled medical consultations and emergency department visits. |
| Medicine intake | At two months after baseline measures (post-intervention), at three and six months. | Using information noted by patients in their Patient's diary. |
Countries
Spain
Outcome results
None listed