NCT03336047

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

November 1, 2017

Last Update Submit

August 3, 2020

Conditions

Keywords

ExerciseActigraphyPrevention and ControlCardiorespiratory Fitness

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 COMPARATOR

Subjects will be encouraged to obtain 10 000 steps a day, monitored by a step counter (fit bit zip)

Behavioral: 10,000 steps daily

using personal activity intelligence

EXPERIMENTAL

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

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
using personal activity intelligence

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).

10,000 steps daily

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Fredrik Hjulstad Bækkerud

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR
  • Ulrik Wisløff, phd prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

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

Locations