ClinicalTrials.gg
CompletedNCT03336047Updated Aug 4, 2020

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

An interventional study of personal activity intelligence and 10,000 steps daily in Obesity and Physical Activity, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-08-04.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 38 studies in Obesity by Norwegian University of Science and Technology — none open to participants now, 3 under way, none of them phase 3. Obesity · Norwegian University of Science and Technology.

Enrollment
33rd of 37
21 · median 46
Started
2017
with 3 others
No phase
37 of 38
none open now
Registered
26th of 38
by date

Among the 38 studies in Obesity by Norwegian University of Science and Technology, this one is the 33rd largest by enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2017, is one of 37 with no phase, and was the 26th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

None of the 38 studies in Obesity by Norwegian University of Science and Technology is open now.

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 30 Years to 50 Years · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 38 studies in Obesity by Norwegian University of Science and Technology as a file.
02

Study 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.

03

Conditions studied

  • Obesity
  • Physical Activity

Keywords

  • Exercise
  • Actigraphy
  • Prevention and Control
  • Cardiorespiratory Fitness
04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Behavioralpersonal 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).

    Also known as: PAI

  • Behavioral10,000 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).

06

What researchers measure

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.

    Time frame: After the intervention period (8 weeks)

Secondary outcomes

  1. Body composition

    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.

    Time frame: After intervention period (8 weeks)

07

Study locations

1 site
  • St. Olavs Hospital
    Trondheim, Sør Trøndelag 7030, Norway
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Feb 2018, 3 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 3 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2017
First posted
Nov 8, 2017
StartActual
Nov 15, 2017
Primary completionActual
Feb 15, 2018
CompletionActual
Feb 15, 2018
Last update
Aug 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03336047
Responsible party
Sponsor
First posted
Nov 8, 2017
Start date
Nov 15, 2017
Primary completion
Feb 15, 2018
Completion
Feb 15, 2018
Last update
Aug 4, 2020

Study contacts

Fredrik Hjulstad Bækkerud
principal investigator · Norwegian University of Science and Technology
Ulrik Wisløff, phd prof
study director · Norwegian University of Science and Technology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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