Effectiveness of a Nordic Walking in Patients With Asthma.

NCT05482620 | Unknown

• 1 other identifier: NORWALKAS RCT
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma

Keywords

Asthma; Physical Therapy, Modalities; Physical Therapy, Speciality; Nordic Walking; Patient Education as Topic; Walk Test; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Number of repetitions in the one-minute sit to stand test (1MSTST)

  At baseline, and at two (post-intervention), three and six months.

• Number of steps per day

  At baseline, and at two (post-intervention), three and six months.

• Average of steps per week

  At two months after baseline measures (post-intervention), at three and six months.

• Time lying down

  At baseline, and at two (post-intervention), three and six months.

• Time sitting

  At baseline, and at two (post-intervention), three and six months.

Other Outcomes (5)

• Medicine intake

  At two months after baseline measures (post-intervention), at three and six months.

• Health care use

  At two months after baseline measures (post-intervention), at three and six months.

• Respiratory Muscle Strength

  At baseline

Study Arms (2)

Study Group

EXPERIMENTAL

Study group following Nordic walking program and educational sessions and usual care (medical visits, medication, etc).

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).

Procedure: Educational sessions and usual care

Interventions

Nordic walking program PROCEDURE

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.

Study Group

Educational sessions and usual care PROCEDURE

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.

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being ≥18 years old.
• Present an asthma diagnosis.
• People that desires participate in the study.
• People able to sign the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade da Coruña: lead
• Sociedad Española de Neumología y Cirugía Torácica (SEPAR), Spain: collaborator
• Colexio Oficial de Fisioterapeutas de Galicia (COFIGA), Spain: collaborator

Study Sites (1)

Faculty of Physiotherapy. The University of A Coruña. Campus Universitario de Oza, number 1.

A Coruña, 15006, Spain

Location

Related Publications (13)

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  PMID: 10839848 BACKGROUND

• Fonseca 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.

  PMID: 20121755 BACKGROUND

• Azevedo 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.

  PMID: 23412110 BACKGROUND

• Plaza 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.

  PMID: 27756657 BACKGROUND

• Mathiowetz 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.

  PMID: 3970660 BACKGROUND

• Hernandez 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.

  PMID: 30672744 BACKGROUND

• Hernandez 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.

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• Juniper 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.

  PMID: 10489826 BACKGROUND

• Fletcher 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.

  PMID: 23877260 BACKGROUND

• Van 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.

  PMID: 22745715 BACKGROUND

• Vilanova-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.

  PMID: 36893205 DERIVED

Related Links

• Calaf N. Medición de las presiones respiratorias máximas. En: Comité científico SEPAR Manual SEPAR de procedimientos: procedimientos de evaluación de la función pulmonar II \[Internet\] \[Internet\]. Barcelona; 2004. p. 134-44.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only investigator making evaluation is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: August 1, 2022
• Study Start: June 13, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 1, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)