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Completed

NCT Number: NCT05486689

Evaluation of Physical Activity in Asthmatic Subjects

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elisabetta Zampogna

Tradate, Va, 21049, Italy

About this study

Asthma is a chronic disease, which leads to a number of adverse outcomes, including possible lower levels of physical activity (PA). Physical inactivity is an important risk factor, it and was shown that training improves cardiopulmonary fitness, symptoms and quality of life. 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. For PA assessments using an accelerometer, recordings of at least 4 weekly days with a minimum of 8 hours of monitor use (during waking hours) are recommended. A recent systematic review showed that adults with asthma had lower levels of total, moderate and vigorous physical activity than those without asthma. Physical activity appears to be influenced by comorbidities such as obesity in addition to age and sex, decreased disease control, and increased severity. Ather authors involved obese subjects with asthma assigned to a 12-month lifestyle intervention dually targeted modest weight loss (achieve and maintain a weight loss of 7% of baseline body weight) and increased physical activity (achieve and maintain a minimum of 150 minutes per week of moderate intensity physical activity) compared with usual care (control group). Moderately and severely obese adults with uncontrolled asthma showed modest average weight reduction and PA improvements. Finally was showed that a comprehensive pulmonary rehabilitation (PR) program including a weight loss program and exercise training improves PA in moderately-severely obese adults with asthma.

There are no data showing the possible effects of a 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 (and standard deviation) 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. This information will be used for formal sample size calculations when planning a future larger study investigating the number of daily steps and time in activity of normal-weight subjects with asthma before and after PR.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Physical activity

    Time frame: 5 days after pulmonary rehabilitation

    number of daily steps

  2. Daily activity

    Time frame: 5 days after pulmonary rehabilitation

    hours spent in activity in a day

Secondary outcomes

  1. health-related quality of life

    Time frame: 1 day after pulmonary rehabilitation

    Asthma Quality of Life Questionnaire (AQLQ), 0-7 (higher score indicating better quality of life)

  2. Asthma control

    Time frame: 1 day after pulmonary rehabilitation

    Asthma Control Test (ACT), 5-25 (higher score indicating better asthma control)

  3. Exercise capacity

    Time frame: 1 day after pulmonary rehabilitation

    Six minute walking test (6MWT)

  4. Quadriceps strength

    Time frame: 1 day after pulmonary rehabilitation

    maximal voluntary strength (MVS)

  5. Biceps strength

    Time frame: 1 day after pulmonary rehabilitation

    maximal voluntary strength (MVS)

  6. Mood

    Time frame: 1 day after pulmonary rehabilitation

    Hospital Anxiety and depression scale (HADS), 0-21 0-50 (higher score indicating worst mood)

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

Evaluation of Physical Activity Before and After Respiratory Rehabilitation in Normal Weight

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2022
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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