NCT05482620

Effectiveness of a Nordic Walking in Patients With Asthma.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Universidade da Coruña · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
PROCEDURE	Nordic 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.
PROCEDURE	Educational 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.

Timeline

• Start date: 2022-06-13
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-08-01
• Last updated: 2022-08-01

Locations

1 site across 1 country: Spain