The Effect of Personal Activity Intelligence Versus 10,000 Steps Daily on Cardiorespiratory Fitness

The Effect of Personal Activity Intelligence Versus 10,000 Steps Daily on Cardiorespiratory Fitness in Overweight and Obese

A high physical fitness can prevent cardiovascular disease. Which form of exercise training is efficient at improving fitness is well known. The challenge is to get people to do it. Personal activity intelligence (PAI) is an algorithm developed for this challenge. It gives a score that tells the users whether they are active enough to achieve the maximum health benefit of exercise based on their heart rate. It has been shown that people who obtain 100 PAI a week have less cardiovascular disease, but intervention studies showing that PAI can improve physical fitness are so far lacking.

Step counters have received a lot of attention and 10 000 steps a day is a common recommendation, but little is known about the physiological adaptations to this intervention.

This study will compare the effect of physical activity with a value of 100 PAI points a week with 10 000 steps a day in healthy, but overweight (body mass index > 25) participants between 30 and 50 years of age.

Study Overview

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sør Trøndelag
      • Trondheim, Sør Trøndelag, Norway, 7030
        • St. Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI) > 25
  • Low physical activity (less than 50 PAI points calculated from a questionnaire)

Exclusion Criteria:

  • Cancer diagnosis
  • Cardiac arrhythmia
  • Angina
  • Previous myocardial infarction
  • lung disease
  • heart disease
  • uncontrolled hypertension
  • kidney disease
  • orthopedic or neurological limitations
  • planned surgery during the intervention
  • participation in other research studies conflicting with the current study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10,000 steps daily
Subjects will be encouraged to obtain 10 000 steps a day, monitored by a step counter (fit bit zip)
Participants randomized to the 10,000 step intervention will receive a fit bit zip step counter and asked to obtain 10.000 steps per day. Participants will be encouraged to obtain 10.000 steps per day by telephone messages (sms).
Experimental: using personal activity intelligence
Subjects will be encouraged to obtain 100 PAI points per week, monitored by Mio Slice and the Mio Pai 2.0 smart phone application

Participants randomized to the PAI intervention will receive a Mio Slice fitness bracelet and asked to install the Mio Pai 2.0 app on their smart phone. This tracks their fitness score based on the PAI algorithm where the goal is to maintain 100 PAI points a week. PAI is earned incrementally based on time spent in three different heart rate zones, low, medium and high intensity. PAI is recorded every day and added to the weekly total and the PAI earned on the same day the previous week is deleted (on Tuesday, the PAI earned the previous Tuesday will disappear).

Participants will be encouraged to maintain 100 PAI during the 8 weeks intervention by telephone messages (sms).

Other Names:
  • PAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal oxygen uptake
Time Frame: After the intervention period (8 weeks)
The highest amount of oxygen the body can take up, achieved at maximal exercise at the end of an incremental treadmill test measured through ergospirometry. The difference between the two groups post-intervention will be used, while controlling for a pre-intervention value.
After the intervention period (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: After intervention period (8 weeks)

Body mass, fat mass and lean mass will be measured using a bio impedance analysis which weighs the participants and uses bio impedance to also assess fat mass and lean mass.

The difference between the two groups post-intervention will be used, while controlling for a pre-intervention value.

After intervention period (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fredrik Hjulstad Bækkerud, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

November 1, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2017/1211

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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