Effectiveness of a Nordic Walking in Patients With Asthma.
- Conditions
- Asthma
- Interventions
- Procedure: Nordic walking programProcedure: Educational sessions and usual care
- Registration Number
- NCT05482620
- Lead Sponsor
- Universidade da Coruña
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 114
- Being ≥18 years old.
- Present an asthma diagnosis.
- People that desires participate in the study.
- People able to sign the informed consent.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Group Nordic walking program Study group following Nordic walking program and educational sessions and usual care (medical visits, medication, etc). Control Group Educational sessions and usual care Group that will only receive educational sessions and usual care (medical visits, medication, etc). Study Group Educational sessions and usual care Study group following Nordic walking program and educational sessions and usual care (medical visits, medication, etc).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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 International Physical Acitvity Questionnaire, short form (IPAQ).
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.
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 two months after baseline measures (post-intervention), at three and six months. 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).
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.
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).
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).
Health Related Quality of Life At baseline, and at two (post-intervention), three and six months. 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.
Trial Locations
- Locations (1)
Faculty of Physiotherapy. The University of A Coruña. Campus Universitario de Oza, number 1.
🇪🇸A Coruña, Spain