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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - clinical diagnosis of a interstitial lung disease.
- - clinically stable in the previous month.
- - ≥ 18 years old.
- - Living at home, assisted-home or at familiar home.
- - cognitive impairments.
- - inability to understand and co-operate.
- - history of neoplasic /immunologic disease or acute cardiac condition or a significant cardiac, musculoskeletal, neuromuscular or psychiatric condition.
- - Participating in pulmonary rehabilitation or have participated in last 6 months.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Alda S. Marques, PhD|
|Principal Investigator Affiliation||School of Health Sciences of the University of Aveiro (ESSUA)|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Interstitial Lung Diseases (ILD)|
Interstitial lung diseases (ILD) comprise the most highly incapacitating group of chronic respiratory diseases, with significant morbidity and high mortality. Physical activity (PA) improves HRQoL, exercise capacity and performance of activities of daily living, control the symptoms and prevent the development of further comorbidities in people with chronic respiratory diseases. However, people with ILD are highly inactive and sedentary and, as the disease progresses, these people spend most of time at home and adhere poorly to interventions, which worsens HRQoL, intensifies clinical decline and increases dependency on others. Home-based PA programmes, integrated in patients' daily routines, may increase PA levels. Lifestyle Integrated Functional Exercise (LiFE) is a home-based PA programme, which integrates training into daily routines. This programme has shown to be effective in healthy older, however its effectiveness in people with a chronic respiratory disease population is unknown. Therefore, this study will develop and implement a home-based PA programme, based on LiFE, in patients with advanced ILD and assess its impacts on PA levels, HRQoL and other health-related domains. The PRIMARY AIM of this study is to assess the effects (short- and mid-term) of a home-based PA programme, based on the LiFE programme, on PA levels and HRQoL of patients with ILD, through a randomised controlled trial (RCT). Secondary aims are to: 1. establish the feasibility of iLiFE and adherence to the intervention; 2. explore the short- and mid-term effects of the iLiFE on the impact of the disease on patients' life, symptoms, exercise tolerance, muscular strength, balance, and emotional status of patients with ILD; 3. assess the cost-benefit of the iLiFE on unscheduled healthcare resources utilisation, length of hospitalisation and number of respiratory infections. To accomplish these aims, a feasibility study and a RCT will be conducted. iLiFE will be individually tailored to address each person's motivations and capacities, within the home context, to ensure the development and implementation of an innovative home-based PA intervention. Thus, it is expected that iLiFE will improve the PA levels of patients with ILD, enhancing HRQoL. Ultimately, this innovative research will potentially reduce health-care utilisation and costs, and finally, guide clinical and research practice, as well as policy decision makers, at a national and international level. Task 1: Literature review. To inform the design of the intervention, the investigators will conduct a systematic review on home-based PA interventions in patients with chronic respiratory diseases according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Task 2: iLiFE-Feasibility study. A mix-methods feasibility study will be conducted to inform the recruitment procedures and components of iLiFE. Sample size will be determined by the qualitative data saturation. The investigators will use a maximum variation strategy to guide recruitment. Ethical approval will be obtained, and data protection will be ensured by following the European regulation. Eligible patients will be identified by general practitioners or by pulmonologists, who will provide a brief explanation about the study and inform the researcher about interest participants. Then, those interested will be contacted and informed consent obtained. Participants will be eligible if are: i) ≥18 years; ii) diagnosed with stable ILD, in an advanced stage, as determined by referred doctor; iii) living at home. Participants will be excluded if: i) have a history of acute cardiac/respiratory condition on the previous month, and ii) present signs of cognitive impairment or significant cardiovascular, neurological and/or musculoskeletal disease, which may limit participation. Data will be collected (approximately 1h) at baseline, 4-weeks (after the programme beginning) and 12-weeks (immediately after the programme). The researcher will collect:
- - Sociodemographic/anthropometric and general clinical data (e.g., smoking habits, number of exacerbations, healthcare utilisation, and hospitalisation): structured questionnaire; - PA (steps per day): accelerometry; - HRQoL: St. George Respiratory Questionnaire; - Impact of the disease on patients' life: COPD Assessment Test (CAT); - Dyspnoea: Modified Medical Research Council questionnaire (mMRC) and modified Borg scale; - Peripheral muscle strength: Handheld dynamometry and handgrip; - Functional capacity: Time Up and Go test; Brief-Balance Evaluation Systems Test and Physical Performance Test; - Exercise tolerance: Chester step test; - Emotional status: Hospital Anxiety and Depression Scale; - Activities of daily living: London Chest Activity of Daily Living; - Self-perception of performance in everyday living: The Canadian Occupational Performance Measure (COPM); - Fatigue: Borg modified scale and Functional Assessment of Chronic Illness Therapy - Fatigue Scale; - Cough and sputum: Cough and Sputum Assessment questionnaire; - Occurrence of adverse events and adherence to the interventions.
- - Weeks 1-4: 3 face-to-face sessions/week; - Weeks 5-8: 2 face-to-face sessions/week and a weekly phone call; - Weeks 9-11: 1 face-to-face session/week and a weekly phone call; - Week 12: 2 phone calls.
Experimental: Home-based physical activity group
The experimental group will receive the iLiFE.
Active Comparator: Control group
The control group will receive a leaflet with exercises and PA recommendations.
Other: - Home-based physical activity programme
iLiFE is a 12-week individualised programme, adapted to the participants' needs and preferences. This programme will be conducted in participants' home and include everyday tasks to train endurance, balance, flexibility and strength. The intervention incudes face-to-face sessions and phone calls. Face-to-face sessions aim to adapt activities to everyday tasks, increase frequency and/or intensity, monitor progress, clarify doubts, motivate higher daily energy expenditure and manage expectations. Phone-calls aim to clarify doubts and to monitor patients' motivation/evolution, following a motivational interview. At the start of the program, the physiotherapist will be present at all sessions, but these face-to-face visits will decrease over time. Patients will also receive a personalised manual (iLiFE manual) with activities to do in their everyday tasks.
Other: - Usual care
Participants will receive a leaflet with exercises and PA recommendations.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.