The Effect of Personal Activity Intelligence Versus 10,000 Steps Daily on Cardiorespiratory Fitness
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Nov 2017
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2017
CompletedFirst Posted
Study publicly available on registry
November 8, 2017
CompletedStudy Start
First participant enrolled
November 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2018
CompletedAugust 4, 2020
August 1, 2020
3 months
November 1, 2017
August 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximal oxygen uptake
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 Outcomes (1)
Body composition
After intervention period (8 weeks)
Study Arms (2)
10,000 steps daily
ACTIVE COMPARATORSubjects will be encouraged to obtain 10 000 steps a day, monitored by a step counter (fit bit zip)
using personal activity intelligence
EXPERIMENTALSubjects will be encouraged to obtain 100 PAI points per week, monitored by Mio Slice and the Mio Pai 2.0 smart phone application
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) \> 25
- Low physical activity (less than 50 PAI points calculated from a questionnaire)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Olavs Hospital
Trondheim, Sør Trøndelag, 7030, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fredrik Hjulstad Bækkerud
Norwegian University of Science and Technology
- STUDY DIRECTOR
Ulrik Wisløff, phd prof
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2017
First Posted
November 8, 2017
Study Start
November 15, 2017
Primary Completion
February 15, 2018
Study Completion
February 15, 2018
Last Updated
August 4, 2020
Record last verified: 2020-08