A Nurse Led Intervention to Promote Physical Activity

NCT04235647 | Completed

• 1 other identifier: DM-72
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

sedentary; older adults; risk factor; intervention; pedometer; clinical trial

Outcome Measures

Primary Outcomes (1)

• Change in total body weight

  3 months

Secondary Outcomes (6)

• Change in body mass index (BMI)

  3 months

• Change in waist circumference

  3 months

• Change in resting heart rate

  3 months

• Change in resting blood pressure

  3 months

• Change in total cholesterol concentration at fasting

  3 months

Study Arms (2)

Study group

EXPERIMENTAL

Older, sedentary adults (age 50-75 years) with and least one other cardiovascular risk-factor

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

Other: Nurse led tutorial on lifestyle management and pedometer hand-out

Interventions

Nurse led tutorial on lifestyle management and pedometer hand-out OTHER

Individual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out

Control group; Study group

Steps goal setting and supporting phone calls OTHER

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

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead
• Józef Piłsudski University of Physical Education: collaborator

Study Sites (1)

NZOZ Arnika

Stare Babice, Ul. Rynek 10, 05-082, Poland

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Łukasz A. Małek, MD, PhD

  Institute of Cardiology in Warsaw

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 22, 2020
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

PL (1)