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Clinical Trials/NCT05318482
NCT05318482
Completed
Not Applicable

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

Istituti Clinici Scientifici Maugeri SpA1 site in 1 country50 target enrollmentMarch 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiorespiratory Failure
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Enrollment
50
Locations
1
Primary Endpoint
Delta change in number of steps per day
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 23, 2022
End Date
July 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

Delta change in number of steps per day

Time Frame: Day 0 and day 17

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.

Secondary Outcomes

  • Delta change in BDI questionnaire(Day 0 and day 17)
  • Delta change in PASE Questionnaire(Day 0 and day 17)
  • Delta change in 6 MWT(Day 0 and day 17)
  • Delta change in EMI-2 questionnaire(Day 0 and day 17)
  • Delta change in SPPB Scale(Day 0 and day 17)
  • Delta change in SF-12 questionnaire(Day 0 and day 17)

Study Sites (1)

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