Evaluation of Physical Activity in Asthmatic Subjects

NCT05486689 | Completed

• 1 other identifier: 2652
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a chronic disease, which leads to a number of adverse outcomes, including lower levels of physical activity (PA). Physical inactivity is an important risk factor, increasing PA has become a patient-centred goal for the treatment of subjects with asthma. Data provided by activity monitors are commonly used to measure daily PA. A recent systematic review showed that adults with asthma had lower levels of total, moderate and vigorous physical activity than those without asthma. There are no data showing the possible effects of a Pulmonary Rehabilitation (PR) program on PA (number of daily steps) in normal-weight subjects with asthma. The main objective of this pilot study is to obtain estimates of the mean value of number of daily steps, time spent on activity in hours and of other variables in normal-weight subjects with asthma measured before and after the PR program. No estimates about these parameters in the same population are currently available from literature search.

Conditions

Asthma; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Physical activity

  number of daily steps

  5 days after pulmonary rehabilitation

• Daily activity

  hours spent in activity in a day

  5 days after pulmonary rehabilitation

Secondary Outcomes (6)

• health-related quality of life

  1 day after pulmonary rehabilitation

• Asthma control

  1 day after pulmonary rehabilitation

• Exercise capacity

  1 day after pulmonary rehabilitation

• Quadriceps strength

  1 day after pulmonary rehabilitation

• Biceps strength

  1 day after pulmonary rehabilitation

Study Arms (1)

Standard Program

EXPERIMENTAL

Pulmonary Rehabilitation

Other: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation OTHER

The enrolled subjects will receivePR program. The 3 weeks inpatient PR will include education, exercise training, nutritional and psychological counselling. Education: individualized session of 20 minutes each and group session of 45 minutes each. Endurance training: at least twelve 30-minute daily sessions of supervised incremental exercise training according to Maltais, continuous cycling at 50-70% of the maximal load calculated on the basis of the baseline 6MWT according to Hill. Strength training: twelve 30-minute daily sessions of peripheral limb muscle strength training: 2 set of 8 repetitions during the first week, increased at 12 from the second. The initial load will be set at 30/50% of maximal voluntary isometric strength (MVS). Psychological intervention: individual tailored intervention will be offered when the Hospital Anxiety and Depression Scale (HADS) score is \>10 or judged necessary by clinicians, after verifying the subject's motivation.

Standard Program

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of asthma according to GINA step 3-5
• body mass index (BMI) between 18.5 and 24.9 kg/m2
• under optimal medical treatment for at least 3 months according to GINA guideline
• able to perform and complete with studies procedures.

You may not qualify if:

• diagnosis of any other chronic pulmonary disease
• smokers or ex-smokers with pack/years ≥10
• acute exacerbation of asthma in the last 30 days
• engagement in exercise training program in the previous 6 months
• history of significant oncological, neurological, cardiovascular diseases
• musculoskeletal impairment
• medical diseases that are likely to compromise mobility and precluding exercise testing and PR
• use of a walker when moving
• reduced spontaneous gait speed (10 m walk test\< at 0.8 m/sec).

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Elisabetta Zampogna

Tradate, Va, 21049, Italy

Location

Related Publications (1)

• Oliva FM, Tarasconi M, Malovini A, Zappa M, Visca D, Zampogna E. Evaluation of physical activity before and after respiratory rehabilitation in normal weight individuals with asthma: a feasibility study. Front Sports Act Living. 2024 May 9;6:1372048. doi: 10.3389/fspor.2024.1372048. eCollection 2024.

  PMID: 38783863 DERIVED

MeSH Terms

Conditions

Asthma; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Dina Visca, Prof

  ICS Maugeri

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Prospective

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: August 3, 2022
• Study Start: June 30, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 5, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)