Acute Coronary SyndromeNCT02679599

Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic

A study testing B-MOBILE-CARDIAC smartphone application and Cardiac rehabilitation as usual in people with Acute Coronary Syndrome and Heart Failure, run by The Miriam Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Acute Coronary Syndrome, Heart Failure, Other Cardiac Conditions Among Cardiac Rehabilitation Participants
What is being tested?: B-MOBILE-CARDIAC smartphone application and Cardiac rehabilitation as usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Apr 2017
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

within one week of starting rehabilitation,
self-report that they can walk for 10 minutes without assistance from others,
were approved for and are planning to complete 12 weeks of rehabilitation,
own a compatible Android phone or are willing to be taught to use one by study staff;
no evidence of cognitive impairment
able to speak and read English,

Show all 9Show fewer

aged 18-75 years,
no known nickel allergy, and
willing to follow the protocol (e.g., carry a smartphone for 16 weeks).

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

The Miriam Hospital
Providence, Rhode Island, 02903

Other trials in United States

About this study

Cardiac rehabilitation patients often fail to exercise as prescribed on days they are not attending rehabilitation and there is a steep drop off in exercise following rehabilitation completion. Moreover, little is known about the amount of time that cardiac rehabilitation patients spend in sedentary behavior, which is associated with increased risk of cardiovascular morbidity and mortality, independent of time spent in exercise. This pilot study aims to test acceptability, feasibility, and preliminary efficacy of a smartphone application (B-MOBILE-CARDIAC) for increasing time spent in moderate-to-vigorous intensity physical activity accumulated in bouts of at least 10 minutes in duration (i.e. bout-related MVPA) and decrease time spent in sedentary behavior. Up to 32 patients will be recruited, enrolled, and randomized during the first 2 weeks of cardiac rehabilitation to either: 1) B-MOBILE-CARDIAC plus cardiac rehabilitation or 2) cardiac rehabilitation alone. Participants will complete 7 days of objective activity monitoring to measure daily minutes spent in bout-related MVPA and sedentary behavior (primary outcomes) at baseline, mid-rehabilitation (6 weeks), end of cardiac rehabilitation (12 weeks), and 4-week follow-up (16 weeks). At these same time points, participants will complete questionnaires assessing sedentary behavior, MVPA, exercise tolerance, health-related quality of life, mood, and affect. At baseline and end of cardiac rehabilitation participants will undergo a blood draw to measure cardiometabolic and inflammatory risk factors and complete a test of cognitive functioning. Feasibility and acceptability of the B-MOBILE-CARDIAC application will be assessed at the 4-week follow-up.

Conditions: Acute Coronary Syndrome, Heart Failure, Other Cardiac Conditions Among Cardiac Rehabilitation Participants
Being tested: B-MOBILE-CARDIAC smartphone application, Cardiac rehabilitation as usual
Medical subject headings: Acute Coronary Syndrome, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

B-MOBILE-CARDIAC smartphone applicationOther
Cardiac rehabilitation as usualBehavioural

Study groups in NCT02679599
Study group	Role	What they receive
Cardiac rehabilitation as usual	Other	Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting). Receives: Behavioral: Cardiac rehabilitation as usual
Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app	Experimental	Participants will receive cardiac rehabilitation as usual, plus access to the B-MOBILE-CARDIAC smartphone application through 4 weeks post-rehabilitation. Receives: Other: B-MOBILE-CARDIAC smartphone application; Behavioral: Cardiac rehabilitation as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in objectively measured time engaged in sedentary behavior
Measured: Change from Baseline to 12 weeks (i.e., end of rehabilitation)
Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Measured: Change from Baseline to 12 weeks (i.e., end of rehabilitation)

Secondary outcomes (17)

Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)
Measured: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Self-reported sedentary behavior (SIT-Q-7d Questionnaire)
Measured: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)
Measured: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Self-reported exercise tolerance (Duke activity status index)
Measured: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Health related quality of life (SF-12 Health Survey)
Measured: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Depressed Mood (Patient Health Questionnaire-9)
Measured: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Affect (Positive Affect Negative Affect Scales)
Measured: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Cognitive status (Montreal Cognitive Assessment score)
Measured: Baseline and 12 weeks (i.e., end of rehabilitation).
Smartphone application acceptability (study specific scale)
Measured: Baseline through 16 weeks.
Change in objectively measured time engaged in sedentary behavior
Measured: Change from Baseline to 16 weeks
Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Measured: Change from Baseline to 16 weeks
Lipid profile
Measured: Baseline and 12 weeks (i.e., end of rehabilitation)
C-reactive protein
Measured: Baseline and 12 weeks (i.e., end of rehabilitation)
haemoglobin A1c (HbA1C)
Measured: Baseline and 12 weeks (i.e., end of rehabilitation)
Blood pressure
Measured: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Waist circumference
Measured: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Body Mass Index (kg/m^2, weight in kilograms, height in meters)
Measured: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Apr 2017

First posted10 Feb 2016 (estimated)
Study startMar 2016
Primary completionApr 2017
Study completionApr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02679599
Sponsor's protocol ID: 215615
Status last verified: Sep 2017
First submitted: 2 Feb 2016
Last updated: 6 Sep 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic
ClinicalTrials.gov ID: NCT02679599
Acronym / sponsor ID: 215615
Conditions: Acute Coronary Syndrome, Heart Failure, Other Cardiac Conditions Among Cardiac Rehabilitation Participants
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: The Miriam HospitalUniversity, hospital or other
Study start: Mar 2016
Primary completion: Apr 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 10 Feb 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cardiac rehabilitation as usual	Other	Behavioral: Cardiac rehabilitation as usualParticipants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting).
Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app	Experimental	Other: B-MOBILE-CARDIAC smartphone application, Behavioral: Cardiac rehabilitation as usualParticipants will receive cardiac rehabilitation as usual, plus access to the B-MOBILE-CARDIAC smartphone application through 4 weeks post-rehabilitation.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

within one week of starting rehabilitation,
self-report that they can walk for 10 minutes without assistance from others,
were approved for and are planning to complete 12 weeks of rehabilitation,
own a compatible Android phone or are willing to be taught to use one by study staff;
no evidence of cognitive impairment

Key exclusion criteria (1 listed)

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
B-MOBILE-CARDIAC smartphone application	Other	Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app
Cardiac rehabilitation as usual	Behavioural	Cardiac rehabilitation as usual, Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app

Primary outcome

Change in objectively measured time engaged in sedentary behavior
Time frame: Change from Baseline to 12 weeks (i.e., end of rehabilitation)
Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Time frame: Change from Baseline to 12 weeks (i.e., end of rehabilitation)

17 secondary outcomes

Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Self-reported sedentary behavior (SIT-Q-7d Questionnaire)
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Self-reported exercise tolerance (Duke activity status index)
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Health related quality of life (SF-12 Health Survey)
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Depressed Mood (Patient Health Questionnaire-9)
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Affect (Positive Affect Negative Affect Scales)
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Cognitive status (Montreal Cognitive Assessment score)
Time frame: Baseline and 12 weeks (i.e., end of rehabilitation).
Smartphone application acceptability (study specific scale)
Time frame: Baseline through 16 weeks.
Change in objectively measured time engaged in sedentary behavior
Time frame: Change from Baseline to 16 weeks
Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
Time frame: Change from Baseline to 16 weeks
Lipid profile
Time frame: Baseline and 12 weeks (i.e., end of rehabilitation)
C-reactive protein
Time frame: Baseline and 12 weeks (i.e., end of rehabilitation)
haemoglobin A1c (HbA1C)
Time frame: Baseline and 12 weeks (i.e., end of rehabilitation)
Blood pressure
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Waist circumference
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
Body Mass Index (kg/m^2, weight in kilograms, height in meters)
Time frame: Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.

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 6 Sep 2017.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 1 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 6 Sep 2017. 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 United States. 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. 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?

Change in objectively measured time engaged in sedentary behavior (time frame: Change from Baseline to 12 weeks (i.e., end of rehabilitation)). The study lists 2 primary outcomes in all. 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 NCT02679599.

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 6 Sep 2017.