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The Effects of Endurance and Strength Training in Subjects With Asthma

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Standard Program + Endurance and Strength training
Standard Program
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Resistance Training, Endurance Training, Quality of Life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of asthma step 4 to 5 under optimal medical treatment for at least 6 months according to GINA guideline
  • Symptomatic despite being on treatment: Asthma Control Test (ACT) score ≥ 20 ≤24
  • Able to perform and complete with studies procedures (FeNO, CPET, Six Minute Walking Test (6MWT), MVS.

Exclusion Criteria:

  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the Global initiative for Obstructive Lung Disease (GOLD) guidelines criteria
  • Smokers or ex-smokers with pack/years ≥10
  • Body Mass Index (BMI) ≥30
  • Change in asthma medications in the last 30 days
  • Cognitive impairment (Mini-Mental State Examination score <22)
  • History of oncological, neurological, cardiovascular diseases, musculoskeletal impairment and/or medical diseases precluding exercise testing and pulmonary rehabilitation

Sites / Locations

  • Istituti Clinici Maugeri PneumologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Program

Strength training

Arm Description

twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks.

twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks twelve 30-minute daily sessions of supervised peripheral limb muscle training, 2 set of 6-12 repetitions

Outcomes

Primary Outcome Measures

asthma related Quality of Life
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)
asthma related Quality of Life
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)

Secondary Outcome Measures

Asthma control
Asthma Control Questionnaire (ACQ-6). Range 0 (best) - 6 (worst)
Eosinophilic airway inflammation
Fractional Exhaled Nitric Oxide (FeNO),
Aerobic capacity
Maximum oxygen capacity (VO2max) assessed by Cardio Pulmonary Exercise Test, (CPET).
Quadriceps and biceps strength
Maximal Voluntary isometric Strength (MVS).
Quadriceps and biceps strength
Maximal Voluntary isometric Strength (MVS).
Treatment satisfaction
Global Perceived Effect (GPE) score 1 (best) - 7 (worst)
Numbers of exacerbations
number of exacerbations in the last 12 months.
Asthma control
Asthma Control Questionnaire (ACQ-6) Range 0 (best) - 6 (worst)
Eosinophilic airway inflammation
Fractional Exhaled Nitric Oxide (FeNO).
Aerobic capacity
Maximum oxygen capacity(VO2max) assessed by Cardio Pulmonary Exercise Test (CPET)

Full Information

First Posted
May 5, 2021
Last Updated
November 17, 2022
Sponsor
Istituti Clinici Scientifici Maugeri SpA
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1. Study Identification

Unique Protocol Identification Number
NCT04935125
Brief Title
The Effects of Endurance and Strength Training in Subjects With Asthma
Official Title
The Effects of Combined Endurance and Strength Training on Quality of Life in Subjects With Moderate-severe Asthma: a Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Emerging evidence suggests that regular exercise can complement medical treatment for asthma. Furthermore there are no specific recommendation on how plan exercise training. To the best of current knowledge, there isn't enough evidence of the effect of a strength training in subjects with asthma. Therefore the aim of this study is to evaluate the short and long term effects of a strength and endurance training compared with endurance training alone in subjects with asthma.
Detailed Description
To the best of current knowledge, there isn't enough evidence of the effect of a strength training in subjects with asthma. Aim of the study is evaluate the short (after pulmonary rehabilitation) and long term (after 12 months) effects of a strength and endurance training compared with endurance training alone in improving quality of life and disease control in subjects with asthma of Global Initiative for Asthma (GINA) stage from 4 to 5.This is a prospective randomized control trial. Subjects with diagnosis of asthma according to the GINA guidelines admitted to a reference centre for inpatient pulmonary rehabilitation will be randomly assigned to study or control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Resistance Training, Endurance Training, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Program
Arm Type
Active Comparator
Arm Description
twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks.
Arm Title
Strength training
Arm Type
Experimental
Arm Description
twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks twelve 30-minute daily sessions of supervised peripheral limb muscle training, 2 set of 6-12 repetitions
Intervention Type
Procedure
Intervention Name(s)
Standard Program + Endurance and Strength training
Intervention Description
Sessions of strength training added to a standard inpatient multidisciplinary programme
Intervention Type
Procedure
Intervention Name(s)
Standard Program
Intervention Description
Standard inpatient multidisciplinary programme (including endurance training)
Primary Outcome Measure Information:
Title
asthma related Quality of Life
Description
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)
Time Frame
4 weeks from enrollment
Title
asthma related Quality of Life
Description
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Asthma control
Description
Asthma Control Questionnaire (ACQ-6). Range 0 (best) - 6 (worst)
Time Frame
4 weeks from enrollment
Title
Eosinophilic airway inflammation
Description
Fractional Exhaled Nitric Oxide (FeNO),
Time Frame
4 weeks from enrollment
Title
Aerobic capacity
Description
Maximum oxygen capacity (VO2max) assessed by Cardio Pulmonary Exercise Test, (CPET).
Time Frame
4 weeks from enrollment
Title
Quadriceps and biceps strength
Description
Maximal Voluntary isometric Strength (MVS).
Time Frame
4 weeks from enrollment
Title
Quadriceps and biceps strength
Description
Maximal Voluntary isometric Strength (MVS).
Time Frame
1 year
Title
Treatment satisfaction
Description
Global Perceived Effect (GPE) score 1 (best) - 7 (worst)
Time Frame
1 year
Title
Numbers of exacerbations
Description
number of exacerbations in the last 12 months.
Time Frame
1 year
Title
Asthma control
Description
Asthma Control Questionnaire (ACQ-6) Range 0 (best) - 6 (worst)
Time Frame
1 year
Title
Eosinophilic airway inflammation
Description
Fractional Exhaled Nitric Oxide (FeNO).
Time Frame
1 year
Title
Aerobic capacity
Description
Maximum oxygen capacity(VO2max) assessed by Cardio Pulmonary Exercise Test (CPET)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of asthma step 4 to 5 under optimal medical treatment for at least 6 months according to GINA guideline Symptomatic despite being on treatment: Asthma Control Test (ACT) score ≥ 20 ≤24 Able to perform and complete with studies procedures (FeNO, CPET, Six Minute Walking Test (6MWT), MVS. Exclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the Global initiative for Obstructive Lung Disease (GOLD) guidelines criteria Smokers or ex-smokers with pack/years ≥10 Body Mass Index (BMI) ≥30 Change in asthma medications in the last 30 days Cognitive impairment (Mini-Mental State Examination score <22) History of oncological, neurological, cardiovascular diseases, musculoskeletal impairment and/or medical diseases precluding exercise testing and pulmonary rehabilitation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabetta Zampogna
Phone
+39 0331829596
Email
elisabetta.zampogna@icsmaugeri.it
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Spanevello
Phone
+390331829111
Email
antonio.spanevello@icsmaugeri.it
Facility Information:
Facility Name
Istituti Clinici Maugeri Pneumologia
City
Tradate
State/Province
Lombardia
ZIP/Postal Code
21049
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina Visca
Phone
+390331829409
Email
dina.visca@icsmaugeri.it
First Name & Middle Initial & Last Name & Degree
Antonio Spanevello, MD

12. IPD Sharing Statement

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The Effects of Endurance and Strength Training in Subjects With Asthma

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