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

NCT ID: NCT05318482

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2024-07-31

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.

Conditions

Cardiorespiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Motivational group

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.

Group Type: EXPERIMENTAL

Motivational group

Intervention Type: BEHAVIORAL

In addition to the activities of the usual rehabilitation program, the PT will perform a daily motivational session of 15 minutes in a 1 patient: 1 physiotherapist modality. On that occasion, the patient will report the number of steps performed the previous day; the physiotherapist will check and promote the increase of 10% in the number of steps for the next day. If the patient fails to achieve the goal, the PT will analyze the reasons with the patient, in order to facilitate the achievement of the goal. The PT will advise on the time and place to perform physical activity and the patients will receive a diary to record his/her progress (number of steps and heart rate, Borg Fatigue and Borg Dyspnea before and after an exercise task). The PT will record all these evaluations on an excel database.

Control

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.

Group Type: SHAM_COMPARATOR

Control group

Intervention Type: OTHER

Besides the activities of the usual rehabilitation program, the patients of this group will be provided by the PT only with the generic recommendations of daily exercise during the in-hospital stay

Interventions

Motivational group

In addition to the activities of the usual rehabilitation program, the PT will perform a daily motivational session of 15 minutes in a 1 patient: 1 physiotherapist modality. On that occasion, the patient will report the number of steps performed the previous day; the physiotherapist will check and promote the increase of 10% in the number of steps for the next day. If the patient fails to achieve the goal, the PT will analyze the reasons with the patient, in order to facilitate the achievement of the goal. The PT will advise on the time and place to perform physical activity and the patients will receive a diary to record his/her progress (number of steps and heart rate, Borg Fatigue and Borg Dyspnea before and after an exercise task). The PT will record all these evaluations on an excel database.

Intervention Type: BEHAVIORAL

Control group

Besides the activities of the usual rehabilitation program, the patients of this group will be provided by the PT only with the generic recommendations of daily exercise during the in-hospital stay

Intervention Type: OTHER

Other Intervention Names

Generic recommendations

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Vitacca, MD

Role: PRINCIPAL_INVESTIGATOR

Istituti Clinici Scientifici Maugeri

Locations

Istituti Clinici Scientifici Maugeri IRCCS

Lumezzane, Brescia, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 28137918 (View on PubMed)

Other Identifiers

CE 2608

Identifier Type: -

Identifier Source: org_study_id