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.
Accelerometers will be used for 1-week (8h/day) before and after the 12-weeks. The COPM will
be used to develop the individualised programme for each patient based on participants'
goals.
Individual semi-structured interviews will be conducted, before and after the programme, to
inform about patients' preferences, perspectives, barriers and facilitators for programme
participation.
iLiFE will be conducted for 12 weeks in participants' homes and will include everyday tasks
to train endurance, balance, flexibility and strength. Activities will include: 1) walking
and/or stair climbing to improve endurance; 2) functional-based incorporated in activities of
daily living, to improve balance (work at the kitchen while standing on one leg), flexibility
(stretch the upper limb when watching TV) and muscle strength (squatting instead of bending
at the waist to close a drawer or to pick things up from the floor). Intensity of training
will be adjusted to perceived exertion confirmed by heart rate and oxygen saturation levels.
PA programme will be individualised and based on the results of the assessment.
At the start of the program, the physiotherapist will be present at all sessions, but these
face-to-face visits will decrease over time using the following schedule:
- - 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.
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. Patients will also receive a
personalised manual (iLiFE manual) with activities to do in everyday tasks.
Task 3: iLiFE randomised controlled trial. Based on the findings of the literature review and feasibility study, the intervention will
be refined.
A sample size calculation was computed for the primary outcome measure (daily steps). Based
on a home-based pulmonary rehabilitation study conducted in patients with chronic obstructive
pulmonary disease, it is anticipated that 42 participants in each group (total=84) will be
needed to detect a between-group difference of 520 steps/day (power=80%, α=0.05, 2-tailed),
assuming a strong correlation among paired measures (r=0.70). Since in respiratory
interventions dropout rates are around 20%, 100 participants will be needed.
Patients will be randomised into experimental group (EG) and control group (CG). The EG will
receive the iLiFE programme described in task 2 and, the CG will receive a leaflet with
exercise and PA recommendations.
Data will be collected as described in task 2, however, follow-up assessments will be
conducted at 3 and 6 months after iLiFE, to assess short- and mid-term results. In this task,
all assessments will be performed by a second researcher blinded to the intervention.
