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

Cardiorespiratory Failure Clinical Trial

Official title:

Effects of Physical Activity of an In-hospital Motivational Program in Cardio-respiratory Patients: a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318482
• Other study ID #: CE 2608
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: March 15, 2025

Study information

• Verified date: February 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Mara Paneroni, MSc
• Phone: 0039+030+8253
• Email: mara.paneroni[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 15, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiorespiratory Failure

Intervention

Behavioral:
• 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.

Other:
• 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

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri IRCCS	Lumezzane	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta change in number of steps per day	To evaluate the impact of a motivational program, by an electronic wristwatch for health tracking dedicated to improving physical activity, on behavioural changes (number of steps per day) in hospitalized patients with COPD and HF, which already have performed a standard rehabilitation program.	Day 0 and day 17
Secondary	Delta change in PASE Questionnaire	The Physical Activity Scale for the Elderly (PASE) is an easily administered and scored instrument that measures the level of physical activity in individuals aged 65 years and older. It is divided into two main sections, one for the activities performed in the spare time, and one for household activities. The total score is obtained by multiplying the time amount spent on each free-time activity (hours/day/week) or household activity (yes/no) by certain values derived empirically for each of them; the sum of all activities correlates with the physical activity level.	Day 0 and day 17
Secondary	Delta change in 6 MWT	The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.; This assessment will include also the Borg Scale for Dyspnoea and Fatigue. They both have a minimum score, 0, and a maximum score, 10. Higher scores indicate greater symptom severity (either for dyspnoea or for fatigue).	Day 0 and day 17
Secondary	Delta change in SPPB Scale	The SPPB Scale evaluates the level of safety in motor ability. It is divided into three items, each ranging from 0 to 4. The first item is balance (the score is assigned according to the difficulty level in keeping balance), the second is walking (the score reflects the amount of time taken to walk a distance of 4 meters), and the third is the 1-Minute-Sit-To-Stand-Test (the score is determined by the number of lifts from sitting to standing, performed within the first 5 seconds in one minute. The sum of the scores for each item may vary from 0, which indicates the complete motor inability, to a maximum of 12, which indicates a total motor autonomy.	Day 0 and day 17
Secondary	Delta change in EMI-2 questionnaire	The EMI (Markland and Hardy, 1993) was developed as a means of assessing participation motives in order to examine such issues as the influence of motives on exercise participation, how such motives might influence the choice of activities undertaken, how affective responses to exercise may be influenced by reasons for exercising and how involvement in physical activity might have a reciprocal influence on participation motives. In particular, the authors developed the instrument to examine questions concerning the functional significance of exercise motives from the perspective of Deci and Ryan's (1985) self-determination theory. It is presented as a list of 51 motivational sentences, each of them is assigned a score from 0 (totally false) to 5 (totally true). The sum of each score is the final result, ranging from a minimum of 0 (absence of motivation to do exercise) to a maximum of 255 (highest motivation to do exercise).	Day 0 and day 17
Secondary	Delta change in SF-12 questionnaire	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.; The SF-12 uses the same eight domains as the SF-36: Limitations in physical activities because of health problems.; Limitations in social activities because of physical or emotional problems; Limitations in usual role activities because of physical health problems; Bodily pain; General mental health (psychological distress and well-being); Limitations in usual role activities because of emotional problems; Vitality (energy and fatigue); General health perceptions. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The PCS includes 6 questions concerning different issues. Two questions are about physical activit	Day 0 and day 17
Secondary	Delta change in BDI questionnaire	The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations.; Twenty-one items were consolidated from those observations and ranked 0-3 for severity. The questionnaire is administered by health professionals. The minimum score is 0 and the maximum score is 63. Higher scores indicate greater symptom severity.	Day 0 and day 17