AsthmaNCT05482620
Effectiveness of a Nordic Walking in Patients With Asthma.
A study testing Nordic walking program in people with Asthma, run by Universidade da Coruña at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Nordic walking program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jun 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being ≥18 years old.
- Present an asthma diagnosis.
- People that desires participate in the study.
- People able to sign the informed consent.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Physiotherapy. The University of A Coruña. Campus Universitario de Oza, number 1.
A Coruña, 15006
About this study
Official title: Parallel-group, Randomized Controlled Trial to Test the Effectiveness of a Nordic Walking Program in Patients With Asthma
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
Read the 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
- Being tested
- Nordic walking program, Educational sessions and usual care
- Keywords
- Asthma, Physical Therapy, Modalities, Physical Therapy, Speciality, Nordic Walking, Patient Education as Topic, Walk Test, Randomized Controlled Trial
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic walking programProcedure or surgery
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.
Educational sessions and usual careProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Study group following Nordic walking program and educational sessions and usual care (medical visits, medication, etc). Receives: Procedure: Nordic walking program; Procedure: Educational sessions and usual care |
| Control Group | Active comparator | Group that will only receive educational sessions and usual care (medical visits, medication, etc). Receives: Procedure: Educational sessions and usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline, and at two (post-intervention), three and six months.
Secondary outcomes (23)
Number of repetitions in the one-minute sit to stand test (1MSTST)
Change in number of repetitions of 1MSTST.
Measured: 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+.
Measured: 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.
Measured: 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+.
Measured: At baseline, and at two (post-intervention), three and six months.
Time sitting
Change in time sitting measured by accelerometry with DynaPort® MM+.
Measured: 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+.
Measured: At baseline, and at two (post-intervention), three and six months.
Time walking
Change in time walking measured by accelerometry with DynaPort® MM+.
Measured: At baseline, and at two (post-intervention), three and six months.
Kilocalories consumed
Change in kilocalories consumed measured by accelerometry with DynaPort ® MM+.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At baseline, and at two (post-intervention), three and six months.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At two months after baseline measures (post-intervention), three and six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start13 Jun 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica (SEPAR), Spain, Colexio Oficial de Fisioterapeutas de Galicia (COFIGA), Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482620
- Sponsor's protocol ID
- NORWALKAS RCT
- Status last verified
- Oct 2021
- First submitted
- 29 Jun 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
PubMed 31613151Kendrick KR, Baxi SC, Smith RM. Usefulness of the modified 0-10 Borg scale in assessing the degree of dyspnea in patients with COPD and asthma. J Emerg Nurs. 2000 Jun;26(3):216-22. doi: 10.1016/s0099-1767(00)90093-x.
PubMed 10839848Fonseca JA, Nogueira-Silva L, Morais-Almeida M, Azevedo L, Sa-Sousa A, Branco-Ferreira M, Fernandes L, Bousquet J. Validation of a questionnaire (CARAT10) to assess rhinitis and asthma in patients with asthma. Allergy. 2010 Aug;65(8):1042-8. doi: 10.1111/j.1398-9995.2009.02310.x. Epub 2010 Feb 1.
PubMed 20121755Azevedo P, Correia de Sousa J, Bousquet J, Bugalho-Almeida A, Del Giacco SR, Demoly P, Haahtela T, Jacinto T, Garcia-Larsen V, van der Molen T, Morais-Almeida M, Nogueira-Silva L, Pereira AM, Rodriguez MR, Silva BG, Tsiligianni IG, Yaman H, Yawn B, Fonseca JA; WHO Collaborative Center for Asthma and Rhinitis, Montpellier. Control of Allergic Rhinitis and Asthma Test (CARAT): dissemination and applications in primary care. Prim Care Respir J. 2013 Mar;22(1):112-6. doi: 10.4104/pcrj.2013.00012.
PubMed 23412110Plaza V, Lopez-Vina A, Cosio BG; en representacion del Comite Cientifico del Proyecto TAI. Test of Adherence to Inhalers. Arch Bronconeumol. 2017 Jul;53(7):360-361. doi: 10.1016/j.arbres.2016.08.006. Epub 2016 Oct 15. No abstract available. English, Spanish.
PubMed 27756657Mathiowetz V, Kashman N, Volland G, Weber K, Dowe M, Rogers S. Grip and pinch strength: normative data for adults. Arch Phys Med Rehabil. 1985 Feb;66(2):69-74.
PubMed 3970660Hernandez G, Garin O, Dima AL, Pont A, Marti Pastor M, Alonso J, Van Ganse E, Laforest L, de Bruin M, Mayoral K, Serra-Sutton V, Ferrer M; ASTRO-LAB Group. EuroQol (EQ-5D-5L) Validity in Assessing the Quality of Life in Adults With Asthma: Cross-Sectional Study. J Med Internet Res. 2019 Jan 23;21(1):e10178. doi: 10.2196/10178.
PubMed 30672744Hernandez G, Garin O, Pardo Y, Vilagut G, Pont A, Suarez M, Neira M, Rajmil L, Gorostiza I, Ramallo-Farina Y, Cabases J, Alonso J, Ferrer M. Validity of the EQ-5D-5L and reference norms for the Spanish population. Qual Life Res. 2018 Sep;27(9):2337-2348. doi: 10.1007/s11136-018-1877-5. Epub 2018 May 16.
PubMed 29767329Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x.
PubMed 10489826Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
PubMed 23877260Van Remoortel H, Raste Y, Louvaris Z, Giavedoni S, Burtin C, Langer D, Wilson F, Rabinovich R, Vogiatzis I, Hopkinson NS, Troosters T; PROactive consortium. Validity of six activity monitors in chronic obstructive pulmonary disease: a comparison with indirect calorimetry. PLoS One. 2012;7(6):e39198. doi: 10.1371/journal.pone.0039198. Epub 2012 Jun 20.
PubMed 22745715Vilanova-Pereira M, Jacome C, Rial Prado MJ, Barral-Fernandez M, Blanco Aparicio M, Fontan Garcia-Boente L, Lista-Paz A. Effectiveness of nordic walking in patients with asthma: A study protocol of a randomized controlled trial. PLoS One. 2023 Mar 9;18(3):e0281007. doi: 10.1371/journal.pone.0281007. eCollection 2023.
PubMed 36893205
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel-group, Randomized Controlled Trial to Test the Effectiveness of a Nordic Walking Program in Patients With Asthma
- ClinicalTrials.gov ID
- NCT05482620
- Acronym / sponsor ID
- NORWALKAS RCT
- Conditions
- Asthma
- Keywords
- Asthma, Physical Therapy, Modalities, Physical Therapy, Speciality, Nordic Walking, Patient Education as Topic, Walk Test, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica (SEPAR), Spain, Colexio Oficial de Fisioterapeutas de Galicia (COFIGA), Spain
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: Nordic walking program, Procedure: Educational sessions and usual careStudy group following Nordic walking program and educational sessions and usual care (medical visits, medication, etc). |
| Control Group | Active comparator | Procedure: Educational sessions and usual careGroup that will only receive educational sessions and usual care (medical visits, medication, etc). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being ≥18 years old.
- Present an asthma diagnosis.
- People that desires participate in the study.
- People able to sign the informed consent.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic walking programNordic 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 or surgery | Study Group |
| Educational sessions and usual careEducational 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. | Procedure or surgery | Control Group, Study Group |
Primary outcome
Six-minute walk test (6MWT) distance
Time frame: 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).
23 secondary outcomes
Number of repetitions in the one-minute sit to stand test (1MSTST)
Time frame: At baseline, and at two (post-intervention), three and six months.
Number of steps per day
Time frame: At baseline, and at two (post-intervention), three and six months.
Average of steps per week
Time frame: At two months after baseline measures (post-intervention), at three and six months.
Time lying down
Time frame: At baseline, and at two (post-intervention), three and six months.
Time sitting
Time frame: At baseline, and at two (post-intervention), three and six months.
Time standing up
Time frame: At baseline, and at two (post-intervention), three and six months.
Time walking
Time frame: At baseline, and at two (post-intervention), three and six months.
Kilocalories consumed
Time frame: At baseline, and at two (post-intervention), three and six months.
Metabolic equivalent of task (MET) consumed
Time frame: At baseline, and at two (post-intervention), three and six months.
Metabolic equivalent of task (MET) consumed
Time frame: At baseline, and at two (post-intervention), three and six months.
Level of physical activity
Time frame: At baseline, and at two (post-intervention), three and six months.
Asthma-related symptoms and asthma control
Time frame: At baseline, and at two (post-intervention), three and six months.
Asthma-related symptoms and asthma control
Time frame: At baseline, and at two (post-intervention), three and six months.
Asthma-related symptoms and asthma control
Time frame: At two months after baseline measures (post-intervention), at three and six months.
Dyspnea
Time frame: At baseline, and at two (post-intervention), three and six months.
Pulmonary function
Time frame: At baseline, and at two (post-intervention), three and six months.
Handgrip Strength
Time frame: At baseline, and at two (post-intervention), three and six months.
Health Related Quality of Life
Time frame: At baseline, and at two (post-intervention), three and six months.
Health Related Quality of Life
Time frame: At baseline, and at two (post-intervention), three and six months.
Qualitative changes in the physical activity done in patient's daily life.
Time frame: 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.
Time frame: At two months after baseline measures (post-intervention), at three and six months.
Quality of sleep
Time frame: At baseline, and at two (post-intervention), three and six months.
Medication adherence and recommendations compliance
Time frame: At two months after baseline measures (post-intervention), three and six months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Background: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Background: PubMed 31613151Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
- Background: PubMed 10839848Kendrick KR, Baxi SC, Smith RM. Usefulness of the modified 0-10 Borg scale in assessing the degree of dyspnea in patients with COPD and asthma. J Emerg Nurs. 2000 Jun;26(3):216-22. doi: 10.1016/s0099-1767(00)90093-x.
- Background: PubMed 20121755Fonseca JA, Nogueira-Silva L, Morais-Almeida M, Azevedo L, Sa-Sousa A, Branco-Ferreira M, Fernandes L, Bousquet J. Validation of a questionnaire (CARAT10) to assess rhinitis and asthma in patients with asthma. Allergy. 2010 Aug;65(8):1042-8. doi: 10.1111/j.1398-9995.2009.02310.x. Epub 2010 Feb 1.
- Background: PubMed 23412110Azevedo P, Correia de Sousa J, Bousquet J, Bugalho-Almeida A, Del Giacco SR, Demoly P, Haahtela T, Jacinto T, Garcia-Larsen V, van der Molen T, Morais-Almeida M, Nogueira-Silva L, Pereira AM, Rodriguez MR, Silva BG, Tsiligianni IG, Yaman H, Yawn B, Fonseca JA; WHO Collaborative Center for Asthma and Rhinitis, Montpellier. Control of Allergic Rhinitis and Asthma Test (CARAT): dissemination and applications in primary care. Prim Care Respir J. 2013 Mar;22(1):112-6. doi: 10.4104/pcrj.2013.00012.
- Background: PubMed 27756657Plaza V, Lopez-Vina A, Cosio BG; en representacion del Comite Cientifico del Proyecto TAI. Test of Adherence to Inhalers. Arch Bronconeumol. 2017 Jul;53(7):360-361. doi: 10.1016/j.arbres.2016.08.006. Epub 2016 Oct 15. No abstract available. English, Spanish.
- Background: PubMed 3970660Mathiowetz V, Kashman N, Volland G, Weber K, Dowe M, Rogers S. Grip and pinch strength: normative data for adults. Arch Phys Med Rehabil. 1985 Feb;66(2):69-74.
- Background: PubMed 30672744Hernandez G, Garin O, Dima AL, Pont A, Marti Pastor M, Alonso J, Van Ganse E, Laforest L, de Bruin M, Mayoral K, Serra-Sutton V, Ferrer M; ASTRO-LAB Group. EuroQol (EQ-5D-5L) Validity in Assessing the Quality of Life in Adults With Asthma: Cross-Sectional Study. J Med Internet Res. 2019 Jan 23;21(1):e10178. doi: 10.2196/10178.
- Background: PubMed 29767329Hernandez G, Garin O, Pardo Y, Vilagut G, Pont A, Suarez M, Neira M, Rajmil L, Gorostiza I, Ramallo-Farina Y, Cabases J, Alonso J, Ferrer M. Validity of the EQ-5D-5L and reference norms for the Spanish population. Qual Life Res. 2018 Sep;27(9):2337-2348. doi: 10.1007/s11136-018-1877-5. Epub 2018 May 16.
- Background: PubMed 10489826Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x.
- Background: PubMed 23877260Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
- Background: PubMed 22745715Van Remoortel H, Raste Y, Louvaris Z, Giavedoni S, Burtin C, Langer D, Wilson F, Rabinovich R, Vogiatzis I, Hopkinson NS, Troosters T; PROactive consortium. Validity of six activity monitors in chronic obstructive pulmonary disease: a comparison with indirect calorimetry. PLoS One. 2012;7(6):e39198. doi: 10.1371/journal.pone.0039198. Epub 2012 Jun 20.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nordic walking program in people with Asthma, run by Universidade da Coruña at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test (6MWT) distance (time frame: At baseline, and at two (post-intervention), three and six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05482620, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.