Effectiveness of a Nordic Walking in Patients With Asthma.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parallel-group, Randomized Controlled Trial to Test the Effectiveness of a Nordic Walking Program in Patients With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Procedure: Nordic walking program
* Procedure: Educational sessions and usual care


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria to perform cardiovascular exercise following American Heart Association (AHA). People meeting exclusion criteria for 6MWT following ATS/ERS criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Study group following Nordic walking program and educational sessions and usual care (medical visits, medication, etc). | Procedure: Nordic walking program<br>* 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.<br>Procedure: Educational sessions and usual care<br>* 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.<br>|
| Active Comparator: Control Group<br>Group that will only receive educational sessions and usual care (medical visits, medication, etc). | Procedure: Educational sessions and usual care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk test (6MWT) distance | Change in the 6MWT distance. The 6MWT will be performed according to the American Thoracic Society / European Respiratory Society recommendations (ATS/ERS). | At baseline, and at two (post-intervention), three and six months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life | Changes in mini-Asthma Quality of Life Questionnaire (miniAQLQ) results, validated in Spanish. It is a 15-questions questionnaire, with seven possible responses, ranged in a 7-point scale from 1='extremely bothered' to 7='not bothered at all' . All questions are equally weighted and the overall score is the mean of the 15 responses. So, the final score can range also from 1 to 7, being 1 the worst punctuation. | At baseline, and at two (post-intervention), three and six months. | 
| Qualitative changes in the physical activity done in patient's daily life. | Changes in physical activity registered by patients in their Patient's Diary will be analysed. | At two months after baseline measures (post-intervention), at three and six months. | 
| Qualitative changes in self-perception of mood in patient's daily life. | Changes in self-perception of mood registered by patients in their Patient's Diary will be analysed. | At two months after baseline measures (post-intervention), at three and six months. | 
| Quality of sleep | 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. | At baseline, and at two (post-intervention), three and six months. | 
| Medication adherence and recommendations compliance | 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. | At two months after baseline measures (post-intervention), three and six months. | 
| Number of repetitions in the one-minute sit to stand test (1MSTST) | Change in number of repetitions of 1MSTST. | At baseline, and at two (post-intervention), three and six months. | 
| Number of steps per day | Change in number of steps per day measured by accelerometry with DynaPort ® MM+. | At baseline, and at two (post-intervention), three and six months. | 
| Average of steps per week | Analysed through Patient's Diary, in where they must register daily number of steps walked. | At two months after baseline measures (post-intervention), at three and six months. | 
| Time lying down | Change in time lying down measured by accelerometry with DynaPort® MM+. | At baseline, and at two (post-intervention), three and six months. | 
| Time sitting | Change in time sitting measured by accelerometry with DynaPort® MM+. | At baseline, and at two (post-intervention), three and six months. | 
| Time standing up | Change in time standing up measured by accelerometry with DynaPort® MM+. | At baseline, and at two (post-intervention), three and six months. | 
| Time walking | Change in time walking measured by accelerometry with DynaPort® MM+. | At baseline, and at two (post-intervention), three and six months. | 
| Kilocalories consumed | Change in kilocalories consumed measured by accelerometry with DynaPort ® MM+. | At baseline, and at two (post-intervention), three and six months. | 
| Metabolic equivalent of task (MET) consumed | Change in MET consumed measured by accelerometry with DynaPort ® MM+ and International Physical Acitvity Questionnaire, short form (IPAQ). | At baseline, and at two (post-intervention), three and six months. | 
| Metabolic equivalent of task (MET) consumed | Change in MET consumed measured by International Physical Acitvity Questionnaire, short form (IPAQ). | At baseline, and at two (post-intervention), three and six months. | 
| Level of physical activity | 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. | At baseline, and at two (post-intervention), three and six months. | 
| Asthma-related symptoms and asthma control | 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. | At baseline, and at two (post-intervention), three and six months. | 
| Asthma-related symptoms and asthma control | Change in Test of Adherence to Inhalers (TAI) results, validated in patients with asthma and in Spanish population. Score range is from 10 to 50, being 10 the worst score. | At baseline, and at two (post-intervention), three and six months. | 
| Asthma-related symptoms and asthma control | Analysed through Patient's Diary, in where they must register some data that the researchers will analyse afterwards (dyspnea measured using Borg's modified scale, in expectoration, cough, feeling of chest wheezing, medicine intake, unscheduled medical consultations, emergency visits, PEF diary measure with a peak flow meter). | At two months after baseline measures (post-intervention), at three and six months. | 
| Dyspnea | Change in dyspnea measured with Modified Medical Research Council scale (mMRC). Scores range from 0 to 4, being 0 the best punctuation. | At baseline, and at two (post-intervention), three and six months. | 
| Pulmonary function | 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). | At baseline, and at two (post-intervention), three and six months. | 
| Handgrip Strength | 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). | At baseline, and at two (post-intervention), three and six months. | 
| Health Related Quality of Life | 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). | At baseline, and at two (post-intervention), three and six months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Physical Therapy, Modalities, Physical Therapy, Speciality, Nordic Walking, Patient Education as Topic, Walk Test, Randomized Controlled Trial