Motivational Program on Physical Activity in Cardio-respiratory Patients: an RCT Study

Istituti Clinici Scientifici Maugeri SpA

Status: Completed

Conditions: Cardiorespiratory Failure

Treatments: Behavioral: Motivational group; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05318482

CE 2608

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Motivational group

Experimental group

Description:

The patients of this group will be equipped with an electronic wristwatch and will be monitored every day by the physiotherapist (PT) through an application on their mobiles. The PT will follow these patients with a daily motivational session (15 minutes, modality 1 patient: 1 PT) and with an educational program about the definition, importance and benefits of physical activity.

Treatment:

Behavioral: Motivational group

Control

Sham Comparator group

Description:

The patients of this group will have an electronic wristwatch and will be advised by the PT only with generic recommendations of daily exercise during the hospitalization, besides the usual activities of the rehabilitation program.

Treatment:

Other: Control group