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

• ClinicalTrials.gov Identifier: NCT03336047
• Recruitment Status: Completed
• First Posted: November 8, 2017
• Last Update Posted: August 4, 2020
• Sponsor: Norwegian University of Science and Technology
• Information provided by (Responsible Party): Norwegian University of Science and Technology

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Physical Activity	Behavioral: personal activity intelligence; Behavioral: 10,000 steps daily	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Personal Activity Intelligence Versus 10,000 Steps Daily on Cardiorespiratory Fitness in Overweight and Obese
• Actual Study Start Date: November 15, 2017
• Actual Primary Completion Date: February 15, 2018
• Actual Study Completion Date: February 15, 2018

Arms and Interventions

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)	Behavioral: 10,000 steps daily; 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	Behavioral: personal activity intelligence; 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 Name: PAI

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Norway

St. Olavs Hospital

Trondheim, Sør Trøndelag, Norway, 7030

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

• Principal Investigator: Fredrik Hjulstad Bækkerud; Norwegian University of Science and Technology
• Study Director: Ulrik Wisløff, phd prof; Norwegian University of Science and Technology

More Information

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT03336047
• Other Study ID Numbers: 2017/1211
• First Posted: November 8, 2017
• Last Update Posted: August 4, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:

Exercise; Actigraphy; Prevention and Control; Cardiorespiratory Fitness