Sedentary BehaviorSTEP-IT-UPNCT04235647
A Nurse Led Intervention to Promote Physical Activity
A study testing Nurse led tutorial on lifestyle management and pedometer hand-out and Steps goal setting and supporting phone calls in people with Sedentary Behavior and Cardiovascular Risk Factor, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
Regular physical activity should be the essence of treatment in patients with cardiovascular risk factors. Unfortunately, these interventions are usually insufficiently promoted and therefore have only limited efficacy. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Sedentary Behavior, Cardiovascular Risk Factor
- What is being tested?
- Nurse led tutorial on lifestyle management and pedometer hand-out and Steps goal setting and supporting phone calls
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2018to 1 Jan 2020
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sedentary lifestyle defined as mean walking distance per day of no more than 3 km as reported by the patients;
- history of at least one of the following conditions: obesity (defined as body mass index ≥30 for I st degree obesity, ≥35 for second degree obesity and ≥40 for third degree obesity), hypertension, diabetes mellitus, dyslipidemia, stable coronary artery disease with or without prior myocardial infarction, peripheral arterial disease, stable arrhythmias, heart failure and/or prior stroke.
Who cannot join
- unstable clinical condition (in the form of unstable coronary artery disease or peripheral arterial disease, unstable heart failure or unstable arrhythmias);
- inability to undertake physical activity due to orthopedic reasons or other disabilities;
- planned changes in pharmacological treatment during the study period;
- lack of will to participate in the study and to sign the the written informed consent for the participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nurse Led Intervention to Promote Physical Activity in Sedentary Older Adults With Cardio-vascular Risk Factors in the Outpatient Setting - a Randomized Controlled Trial
Regular physical activity should be the essence of treatment in patients with cardiovascular risk factors. Unfortunately, these interventions are usually insufficiently promoted and therefore have only limited efficacy. The aim of the study was to determine the benefits of nurse led intervention to promote physical activity in sedentary older adults with cardio-vascular risk factors in the outpatient setting. Eligible patients are randomized in a 1:1 fashion to receive nurse led tutorial on life-style modification including pedometer hand-out with a daily goal of at least 7000 steps and supporting phone calls (study group) or without a goal or calls (control group). The primary end-point of the study is change in body weight. Secondary end-points include changes in resting heart rate, systolic and diastolic blood pressure, total cholesterol and fasting glucose and clinical outcomes at 3 months follow-up.
- Conditions
- Sedentary Behavior, Cardiovascular Risk Factor
- Being tested
- Nurse led tutorial on lifestyle management and pedometer hand-out, Steps goal setting and supporting phone calls
- Keywords
- sedentary, older adults, risk factor, intervention, pedometer, clinical trial
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse led tutorial on lifestyle management and pedometer hand-outOther
Individual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out
Steps goal setting and supporting phone callsOther
A goal of minimum 7000 steps per day, phone calls to assess the goal meeting and to support goal achievement every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Older, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor Receives: Other: Nurse led tutorial on lifestyle management and pedometer hand-out; Other: Steps goal setting and supporting phone calls |
| Control group | Active comparator | Older, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor Receives: Other: Nurse led tutorial on lifestyle management and pedometer hand-out |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total body weight
Measured: 3 months
Secondary outcomes (6)
Change in body mass index (BMI)
Measured: 3 months
Change in waist circumference
Measured: 3 months
Change in resting heart rate
Measured: 3 months
Change in resting blood pressure
Measured: 3 months
Change in total cholesterol concentration at fasting
Measured: 3 months
Change in glucose concentration at fasting
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Oct 2018
- Primary completion1 Oct 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Józef Piłsudski University of Physical Education
- Responsible party
- Sponsor
- Investigators
- Łukasz A. Małek, MD, PhD, Study chair, Institute of Cardiology in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235647
- Sponsor's protocol ID
- DM-72
- Acronym
- STEP-IT-UP
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse Led Intervention to Promote Physical Activity in Sedentary Older Adults With Cardio-vascular Risk Factors in the Outpatient Setting - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04235647
- Acronym / sponsor ID
- STEP-IT-UP / DM-72
- Conditions
- Sedentary Behavior, Cardiovascular Risk Factor
- Keywords
- sedentary, older adults, risk factor, intervention, pedometer, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Józef Piłsudski University of Physical Education
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 22 Jan 2020 (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.
Regular physical activity should be the essence of treatment in patients with cardiovascular risk factors. Unfortunately, these interventions are usually insufficiently promoted and therefore have only limited efficacy. The aim of the study was to determine the benefits of nurse led intervention to promote physical activity in sedentary older adults with cardio-vascular risk factors in the outpatient setting. Eligible patients are randomized in a 1:1 fashion to receive nurse led tutorial on life-style modification including pedometer hand-out with a daily goal of at least 7000 steps and supporting phone calls (study group) or without a goal or calls (control group). The primary end-point of the study is change in body weight. Secondary end-points include changes in resting heart rate, systolic and diastolic blood pressure, total cholesterol and fasting glucose and clinical outcomes at 3 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Nurse led tutorial on lifestyle management and pedometer hand-out, Other: Steps goal setting and supporting phone callsOlder, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor |
| Control group | Active comparator | Other: Nurse led tutorial on lifestyle management and pedometer hand-outOlder, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sedentary lifestyle defined as mean walking distance per day of no more than 3 km as reported by the patients;
- history of at least one of the following conditions: obesity (defined as body mass index ≥30 for I st degree obesity, ≥35 for second degree obesity and ≥40 for third degree obesity), hypertension, diabetes mellitus, dyslipidemia, stable coronary artery disease with or without prior myocardial infarction, peripheral arterial disease, stable arrhythmias, heart failure and/or prior stroke.
Key exclusion criteria (4 listed)
- unstable clinical condition (in the form of unstable coronary artery disease or peripheral arterial disease, unstable heart failure or unstable arrhythmias);
- inability to undertake physical activity due to orthopedic reasons or other disabilities;
- planned changes in pharmacological treatment during the study period;
- lack of will to participate in the study and to sign the the written informed consent for the participation in the study.
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 |
|---|---|---|
| Nurse led tutorial on lifestyle management and pedometer hand-outIndividual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out | Other | Control group, Study group |
| Steps goal setting and supporting phone callsA goal of minimum 7000 steps per day, phone calls to assess the goal meeting and to support goal achievement every 2 weeks | Other | Study group |
Primary outcome
Change in total body weight
Time frame: 3 months
6 secondary outcomes
Change in body mass index (BMI)
Time frame: 3 months
Change in waist circumference
Time frame: 3 months
Change in resting heart rate
Time frame: 3 months
Change in resting blood pressure
Time frame: 3 months
Change in total cholesterol concentration at fasting
Time frame: 3 months
Change in glucose concentration at fasting
Time frame: 3 months
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 22 Jan 2020.
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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.
Łukasz A. Małek, MD, PhD study chair
Institute of Cardiology in Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse led tutorial on lifestyle management and pedometer hand-out and Steps goal setting and supporting phone calls in people with Sedentary Behavior and Cardiovascular Risk Factor, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 2 inclusion and 4 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 22 Jan 2020. 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 Poland. 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 total body weight (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2020.