Using nature-based exercise and inhalers to help people with chronic obstructive pulmonary disease get better

Green Exercise and Aerosol Inhalation for the Rehabilitation of COPD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13915160

Enrollment

Registered

2024-12-04

Start date

2023-04-26

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation of patients with chronic obstructive pulmonary disease (COPD) Respiratory

Interventions

Participants are randomly assigned to three study arms, i.e., two intervention groups (A: aerosol intervention, B: exercise intervention) and one waiting list control group. Randomization is done usin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 40 - 75 years 2. Diagnosis of mild to moderate, irreversible airway obstruction (Schirnhofer et al. 2007) 3. Pulmonary function values of FEV1/FVC 350m in the 6-Minute Walk Test)

Exclusion criteria

Exclusion criteria: 1. Acute counterindication 1.1. Acute exacerbation during the intervention period (T1-T2) 1.2. Optimization of pharmacotherapy 1st trimester 4. Factors that hinder or do not allow self-management: 4.1. Cognitive impairment (Montreal Cognitive Assessment score 19) 4.3. Alcohol or substance abuse (except for nicotine) 5. Participation in a pulmonary rehabilitation program (inpatient or outpatient) within the period of the clinical trial and less than 2 months before 6. Participation in another clinical trial within the clinical trial period and less than 4 weeks before

Design outcomes

Primary

Measure	Time frame
Primary outcomes will be measured at four time points: T1: baseline, day 0 T2: follow-up 1, day 14 T3: follow-up 2, day 90 T4: follow-up 3, day 180 1. Endurance performance is measured using the 6-Minute Walk Test (6MWT) at T1, T2, T3, and T4. 2. Disease-related quality of life is measured using the Saint George's Respiratory Questionnaire (SGRQ) at T1, T2, T3, and T4. 3. Respiratory muscle strength is measured using the spirometry parameters Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at T1, T2, T3, and T4. 4. Sympathetic activity at the waterfall or control site measured using tidal volume, and respiratory rate at T1 and T2 (short-term effects).	—

Measure

Time frame

Primary outcomes will be measured at four time points: T1: baseline, day 0 T2: follow-up 1, day 14 T3: follow-up 2, day 90 T4: follow-up 3, day 180 1. Endurance performance is measured using the 6-Minute Walk Test (6MWT) at T1, T2, T3, and T4. 2. Disease-related quality of life is measured using the Saint George's Respiratory Questionnaire (SGRQ) at T1, T2, T3, and T4. 3. Respiratory muscle strength is measured using the spirometry parameters Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at T1, T2, T3, and T4. 4. Sympathetic activity at the waterfall or control site measured using tidal volume, and respiratory rate at T1 and T2 (short-term effects).

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Secondary

Measure	Time frame
Secondary outcomes will be measured at four time points: T1: baseline, day 0 T2: follow-up 1, day 14 T3: follow-up 2, day 90 T4: follow-up 3, day 180 1. Vital parameters 1a. Body composition measured using bioelectrical impedance analysis at T1, T2, T3, and T4. 1b. Body height and weight measured using scales at T1, T2, T3, and T4. 1c. Blood pressure measured using blood pressure monitors at T1, T2, T3, and T4. 1d. Oxigen saturation will be measured using near-infrared spectroscopy at T1, T2, T3, and T4. 2. Lung function paramters 2a. Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) measured using spirometry at T1, T2, T3, and T4. 2b. Diffusion capacity (TLCO) measured using lung diffusion testing at T1, T2, T3, and T4. 3. Laboratory parameters 3a. Complete blood count and cytokines (e.g., IL-5, IL-10) in venous blood measured using Flow Cytometry and immunoassay at T1, T2, T3, and T4. 3b. Immunoglobulin A in saliva samples measured using enzyme-linked immunoassay (ELISA) at T1, T2, T3, and T4. 4. Health-related quality of life measured using a survey at T1, T2, T3, and T4 including the following questionnaires: 4a. Short-Form-12 4b. EQ-5-DL 4c. WHO-5 4d. SF-36 5. Disease-related symptoms and quality of life measured using a survey at T1, T2, T3, and T4 including the following questionnaires: 5a. COPD Assessment Test (CAT) 5b. Clinical COPD Questionnaire (CCQ) 5c. Illness Cognition Questionnaire (ICQ) 5d. COPD Anxiety Questionnaire (CAF) 5e. Hospital Anxiety and Depression Scale (HADS) 6. Training motivation measured using a survey at T1, T2, T3, and T4 including the following questionnaires: 6a. Treatment-Self-Regulation (TSRS) 7. Cognitive performance measured using the Digit Symbol Substitution Test (DSST) at T1, T2, T3, and T4. 8. Training adherence in the follow-up phase measured using a survey at T1, T2, T3, and T4 including the following tools: 8a. A training diary with a protocol of training frequency and dur	—

Measure

Time frame

Secondary outcomes will be measured at four time points: T1: baseline, day 0 T2: follow-up 1, day 14 T3: follow-up 2, day 90 T4: follow-up 3, day 180 1. Vital parameters 1a. Body composition measured using bioelectrical impedance analysis at T1, T2, T3, and T4. 1b. Body height and weight measured using scales at T1, T2, T3, and T4. 1c. Blood pressure measured using blood pressure monitors at T1, T2, T3, and T4. 1d. Oxigen saturation will be measured using near-infrared spectroscopy at T1, T2, T3, and T4. 2. Lung function paramters 2a. Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) measured using spirometry at T1, T2, T3, and T4. 2b. Diffusion capacity (TLCO) measured using lung diffusion testing at T1, T2, T3, and T4. 3. Laboratory parameters 3a. Complete blood count and cytokines (e.g., IL-5, IL-10) in venous blood measured using Flow Cytometry and immunoassay at T1, T2, T3, and T4. 3b. Immunoglobulin A in saliva samples measured using enzyme-linked immunoassay (ELISA) at T1, T2, T3, and T4. 4. Health-related quality of life measured using a survey at T1, T2, T3, and T4 including the following questionnaires: 4a. Short-Form-12 4b. EQ-5-DL 4c. WHO-5 4d. SF-36 5. Disease-related symptoms and quality of life measured using a survey at T1, T2, T3, and T4 including the following questionnaires: 5a. COPD Assessment Test (CAT) 5b. Clinical COPD Questionnaire (CCQ) 5c. Illness Cognition Questionnaire (ICQ) 5d. COPD Anxiety Questionnaire (CAF) 5e. Hospital Anxiety and Depression Scale (HADS) 6. Training motivation measured using a survey at T1, T2, T3, and T4 including the following questionnaires: 6a. Treatment-Self-Regulation (TSRS) 7. Cognitive performance measured using the Digit Symbol Substitution Test (DSST) at T1, T2, T3, and T4. 8. Training adherence in the follow-up phase measured using a survey at T1, T2, T3, and T4 including the following tools: 8a. A training diary with a protocol of training frequency and dur

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Countries

Austria

Contacts

Public ContactArnulf Hartl

arnulf.hartl@pmu.ac.at+43 (0)662 2420 80530

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026