Cardiorespiratory FailureNCT05318482
Motivational Program on Physical Activity in Cardio-respiratory Patients: an RCT Study
A study testing Motivational group in people with Cardiorespiratory Failure, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiorespiratory Failure
- What is being tested?
- Motivational group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Istituti Clinici Scientifici Maugeri IRCCS
Lumezzane, Brescia, 25065
About this study
Official title: Effects of Physical Activity of an In-hospital Motivational Program in Cardio-respiratory Patients: a Randomized Control Trial
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).
Read the 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
- Being tested
- Motivational group, Control group
- Keywords
- Rehabilitation, behaviour, COPD, heart failure, tracing
- Medical subject headings
- Behavior, Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational groupBehavioural
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 groupOther
Also called Generic recommendations
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 and day 17
Secondary outcomes (6)
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.
Measured: Day 0 and day 17
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).
Measured: Day 0 and day 17
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.
Measured: Day 0 and day 17
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).
Measured: Day 0 and day 17
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
Measured: Day 0 and day 17
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.
Measured: Day 0 and day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start23 Mar 2022
- Primary completion1 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiorespiratory FailureStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cardio-respiratory patients (COPD and CHF), with similar comorbidity, needing rehabilitation, will be consecutively enrolled at Istituti Clinici Scientifici Maugeri.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Vitacca, MD, Principal investigator, Istituti Clinici Scientifici Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318482
- Sponsor's protocol ID
- CE 2608
- Status last verified
- Nov 2024
- First submitted
- 30 Mar 2022
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protocol submitted to technical and Scientific Committee and Ethical Committee
Publications
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.
PubMed 28137918
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity of an In-hospital Motivational Program in Cardio-respiratory Patients: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05318482
- Acronym / sponsor ID
- CE 2608
- Conditions
- Cardiorespiratory Failure
- Keywords
- Rehabilitation, behaviour, COPD, heart failure, tracing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cardio-respiratory patients (COPD and CHF), with similar comorbidity, needing rehabilitation, will be consecutively enrolled at Istituti Clinici Scientifici Maugeri.
| Arm | Type | Receives |
|---|---|---|
| Motivational group | Experimental | Behavioral: Motivational groupThe 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. |
| Control | Sham comparator | Other: Control groupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational groupIn 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. | Behavioural | Motivational group |
| Control groupAlso: Generic recommendationsBesides 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 | Other | Control |
Primary outcome
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.
6 secondary outcomes
Delta change in PASE Questionnaire
Time frame: Day 0 and day 17
Delta change in 6 MWT
Time frame: Day 0 and day 17
Delta change in SPPB Scale
Time frame: Day 0 and day 17
Delta change in EMI-2 questionnaire
Time frame: Day 0 and day 17
Delta change in SF-12 questionnaire
Time frame: Day 0 and day 17
Delta change in BDI questionnaire
Time frame: Day 0 and day 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Background: PubMed 28137918Demeyer 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.
- Individual participant dataSharing planned: No. Protocol submitted to technical and Scientific Committee and Ethical Committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Vitacca, MD principal investigator
Istituti Clinici Scientifici Maugeri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational group in people with Cardiorespiratory Failure, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta change in number of steps per day (time frame: Day 0 and day 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.