Clinical trial NCT05482620: Effectiveness of a Nordic Walking in Patients With Asthma.
Official title: Parallel-group, Randomized Controlled Trial to Test the Effectiveness of a Nordic Walking Program in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Asthma
Physical Therapy, Modalities
Physical Therapy, Speciality
Nordic Walking
Patient Education as Topic
Walk Test
Randomized Controlled Trial
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica (SEPAR), Spain
name: Colexio Oficial de Fisioterapeutas de Galicia (COFIGA), Spain
First posted: 2022-08-01
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Six-minute walk test (6MWT) distance
timeFrame: At baseline, and at two (post-intervention), three and six months.
Secondary outcomes:
measure: Number of repetitions in the one-minute sit to stand test (1MSTST)
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Number of steps per day
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Average of steps per week
timeFrame: At two months after baseline measures (post-intervention), at three and six months.
measure: Time lying down
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Time sitting
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Time standing up
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Time walking
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Kilocalories consumed
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Metabolic equivalent of task (MET) consumed
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Metabolic equivalent of task (MET) consumed
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Level of physical activity
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Asthma-related symptoms and asthma control
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Asthma-related symptoms and asthma control
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Asthma-related symptoms and asthma control
timeFrame: At two months after baseline measures (post-intervention), at three and six months.
measure: Dyspnea
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Pulmonary function
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Handgrip Strength
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Health Related Quality of Life
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Health Related Quality of Life
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Qualitative changes in the physical activity done in patient's daily life.
timeFrame: At two months after baseline measures (post-intervention), at three and six months.
measure: Qualitative changes in self-perception of mood in patient's daily life.
timeFrame: At two months after baseline measures (post-intervention), at three and six months.
measure: Quality of sleep
timeFrame: At baseline, and at two (post-intervention), three and six months.
measure: Medication adherence and recommendations compliance
timeFrame: At two months after baseline measures (post-intervention), three and six months.
Other outcomes:
measure: Medicine intake
timeFrame: At two months after baseline measures (post-intervention), at three and six months.
measure: Health care use
timeFrame: At two months after baseline measures (post-intervention), at three and six months.
measure: Respiratory Muscle Strength
timeFrame: At baseline
measure: Adverse effects
timeFrame: During intervention, at two months after baseline measures (post-intervention), three and six months.
measure: Satisfaction of Nordic walking group with intervention given
timeFrame: At two months after baseline measures (post-intervention).
Locations:
city: A Coruña
country: Spain
facility: Faculty of Physiotherapy. The University of A Coruña. Campus Universitario de Oza, number 1.
Study officials:
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