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

NCT05318482 | Completed

• 1 other identifier: CE 2608
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiorespiratory Failure

Keywords

Rehabilitation; behaviour; COPD; heart failure; tracing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Delta change in PASE Questionnaire

  Day 0 and day 17

• Delta change in 6 MWT

  Day 0 and day 17

• Delta change in SPPB Scale

  Day 0 and day 17

• Delta change in EMI-2 questionnaire

  Day 0 and day 17

• Delta change in SF-12 questionnaire

  Day 0 and day 17

Study Arms (2)

Motivational group

EXPERIMENTAL

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.

Behavioral: Motivational group

Control

SHAM COMPARATOR

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.

Other: Control group

Interventions

Motivational group 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.

Motivational group

Control group 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

Also known as: Generic recommendations

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri IRCCS

Lumezzane, Brescia, 25065, Italy

Location

Related 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.

  PMID: 28137918 BACKGROUND

MeSH Terms

Conditions

Behavior; Pulmonary Disease, Chronic Obstructive; Heart Failure

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Michele Vitacca, MD

  Istituti Clinici Scientifici Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cardio-respiratory patients (COPD and CHF), with similar comorbidity, needing rehabilitation, will be consecutively enrolled at Istituti Clinici Scientifici Maugeri.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 8, 2022
• Study Start: March 23, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 31, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)