Clinical trial NCT05318482: Motivational Program on Physical Activity in Cardio-respiratory Patients: an RCT Study
Official title: Effects of Physical Activity of an In-hospital Motivational Program in Cardio-respiratory Patients: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiorespiratory Failure
Keywords: Rehabilitation
behaviour
COPD
heart failure
tracing
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cardio-respiratory patients (COPD and CHF), with similar comorbidity, needing rehabilitation, will be consecutively enrolled at Istituti Clinici Scientifici Maugeri.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: According to actual scientific evidence, the interventions on the general population aiming at regular physical activity are one of the most efficient strategies for health improvement. Regardless of this evidence, there is a large part of the elderly population does not adhere to the recommendations of the international guidelines on daily physical activity.

This is even more evident in patients with chronic respiratory and cardiological disease because exercise exacerbates existing symptoms of breathlessness.

This study aims to evaluate the impact of an in-hospital motivational program dedicated to increasing physical activity. With the data of an electronic wristwatch that keeps records of movement, the health professionals incentive an increase in physical activity leading to long term behavioural changes (evaluated by the number of steps per day) in hospitalized patients with COPD and HF, which already perform a standard rehabilitation program (14 sessions).

Detailed description: There are studies in the literature that have reported, in comparison with healthy subjects, a lower level of physical activity in COPD patients; other studies associate less physical activity with increased risk of hospitalization and mortality, which is even more evident considering patients with chronic respiratory diseases. In the same way, patients with Heart Failure (HF) reduce their activity and exercise capacity increasing hospitalization and mortality.

With more fatigue and dyspnoea, a vicious circle is created, with a consequent further reduction of levels of physical activity and worsening of symptoms.

Therefore, it is necessary to provide augmented physical activity in rehabilitation hospital environments.

Rehabilitation is a way to encourage and support patients to achieve their best physical condition. At present, COPD and HF patients admitted in rehabilitative cardio-respiratory wards dedicate a limited amount of time to physical activity, when referred to the entire day of hospitalization, whereas the rest of their time is spent in a sedentary condition. Thus, it is difficult to imagine that an actual change in the patients' lifestyle can be obtained by such a cardio-respiratory rehabilitation.

Eligibility criteria: Inclusion Criteria:

* \>18 years, both of genders;
* Scheduled time of hospitalization of at least 14-16 days;
* Ability to walk by themselves, with safety (SPPB \>10);
* Hospital admission with a diagnosis of COPD (GOLD III-IV, B-D), with or without respiratory failure, or HF (NYHA II-III), sufficiently stabilized with a specific pharmacological therapy
* Possession of a smartphone and ability to use the app for health tracking.

Exclusion Criteria:

* Significant symptoms of the primary disorder, not properly stabilized;
* Hemodynamic and clinic instability;
* Musculoskeletal issues or other types (neurological, orthopedical...), which involve an important limitation in physical exercise performance;
* Medical comorbidities with a life expectancy shorter than one year;
* Clinical signs of cognitive impairment (MMSE \< 25).

Primary outcomes:
measure: Delta change in number of steps per day
timeFrame: Day 0 and day 17
Secondary outcomes:
measure: Delta change in PASE Questionnaire
timeFrame: Day 0 and day 17
measure: Delta change in 6 MWT
timeFrame: Day 0 and day 17
measure: Delta change in SPPB Scale
timeFrame: Day 0 and day 17
measure: Delta change in EMI-2 questionnaire
timeFrame: Day 0 and day 17
measure: Delta change in SF-12 questionnaire
timeFrame: Day 0 and day 17
measure: Delta change in BDI questionnaire
timeFrame: Day 0 and day 17
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS
state: Brescia
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri
name: Michele Vitacca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demeyer H, Louvaris Z, Frei A, Rabinovich RA, de Jong C, Gimeno-Santos E, Loeckx M, Buttery SC, Rubio N, Van der Molen T, Hopkinson NS, Vogiatzis I, Puhan MA, Garcia-Aymerich J, Polkey MI, Troosters T; Mr Papp PROactive study group and the PROactive consortium. Physical activity is increased by a 12-week semiautomated telecoaching programme in patients with COPD: a multicentre randomised controlled trial. Thorax. 2017 May;72(5):415-423. doi: 10.1136/thoraxjnl-2016-209026. Epub 2017 Jan 30.