Effects of Pilates Exercises in Asthmatic Patients

NCT03670654 | Unknown DMC

• 1 other identifier: EPEAP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a chronic respiratory disease with high prevalence worldwide, considered an important cause of morbidity, mortality and high economic costs. Aerobic physical exercise has great merit as non-pharmacological treatment and other exercise modalities have being studied. However, there are few data in the literature about the effects of Pilates method in patients with asthma. The objective of this study is evaluate the effects of a program of exercise using Pilates on health factors related to quality of life in patients with moderate or severe persistent asthma. Patients will be also evaluated about disease control, anxiety and depression symptoms, functional capacity, lung function, respiratory muscle strength, thoracoabdominal mechanics and level of daily life physical activity. The investigators' hypothesis is that strengthening of the deep trunk muscles promotes a mechanical fixation of the thorax, contributing to the clinical improvement of patients with asthma.

Conditions

Asthma

Keywords

Asthma; Exercise; Pilates; Quality of life; Clinical control

Outcome Measures

Primary Outcomes (1)

• Change in health related quality of life

  Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ). The AQLQ is composed by 32 items rated on a 7-point scale ranging from 7 = without limitation to 1 = maximum limitation and grouped in 4 domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). Total score will be obtained by the average of the 32 items. The score of each domain will be obtained by the average of the items that compose the domain. A higher score indicates a better quality of life in relation asthma disease and a minimal important difference of 0.5 points results in clinically improvement or deterioration for total score and for each domain.

  Change from baseline after 3 months of intervention

Secondary Outcomes (7)

• Change in clinical control

  Change from baseline after 3 months of intervention

• Change in the level of anxiety and depression

  Change from baseline after 3 months of intervention

• Change in thoracoabdominal mechanics

  Change from baseline after 3 months of intervention

• Change in respiratory muscle strength

  Change from baseline after 3 months of intervention

• Change in pulmonary function

  Change from baseline after 3 months of intervention

Other Outcomes (1)

• Change in anthropometric dates

  Change from baseline after 3 months of intervention

Study Arms (2)

Pilates Method

ACTIVE COMPARATOR

The intervention of active comparator will be Pilates Method exercises.

Other: Pilates

Muscle stretching exercises

SHAM COMPARATOR

The intervention of sham comparator will be muscle stretching exercises.

Other: Muscle stretching

Interventions

Pilates OTHER

The Pilates exercises will be performed in 12 weeks with 40-minute sessions, three times a week: 2 at ambulatory and 1 at home. Ambulatory sessions will be supervised by a physical therapist in non-consecutive days. Patients could be grouped in classes with a maximum of 4 subjects. The first two weeks will be spent learning the technique and, in the third week, patients will receive an exercise booklet for in-home training. Will be used the classical solo Pilates exercises, adapted for non-trained individuals. Before and after each session, patients will be evaluated in relation to expiratory peak flow, blood pressure, heart rate and asthma symptoms.

Pilates Method

Muscle stretching OTHER

The muscle stretching exercises will be performed in 12 weeks with 40-minute sessions, three times a week: 2 at ambulatory and 1 at home. Ambulatory sessions will be supervised by a physical therapist in non-consecutive days. Patients could be grouped in classes with a maximum of 4 subjects. Patients will practice muscle stretching exercises for principal muscle groups, performed with 3 repetitions, 15 seconds sustain and 1 minute interval. Before and after each session, the patients will be evaluated in relation to expiratory peak flow, blood pressure, heart rate and asthma symptoms.

Muscle stretching exercises

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Asthma moderate and severe
• Asthma will diagnosed (Global Initiative for Asthma -GINA)
• Asthma medication according recommendations from GINA
• Body Mass Index ≥18.5 kg/m2 and \<35 kg/m2
• Sedentary
• Medical treatment, for at least 6 months
• Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)

You may not qualify if:

• Current or ex-smokers (who have given up smoking less than 1 year and/or tobacco charge greater than 10 pack-years)
• Cardiovascular, musculoskeletal and other chronic lung diseases
• Pregnant
• Active cancer
• Uncontrolled hypertension or diabetes
• Continuous use of oral corticosteroid
• Psychiatric disease or cognitive deficit

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Sao Paulo: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, 05360-160, Brazil

Location

MeSH Terms

Conditions

Asthma; Motor Activity

Interventions

Exercise Movement Techniques; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Celso RF Carvalho, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All the measurements will be performed by a blinded professional, who will be masked from randomization and other results. For each test, the same investigator will be maintained before and after the intervention. The participants will know what treatment (exercise) they will receive, but they don't will know what exercise belongs to the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 13, 2018
• Study Start: August 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: December 14, 2018
• Last Updated: September 13, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)