NCT04827212

Companion: Sensor-based Two-way Communication for Physical Activity in Older Adults

Completed EARLY_PHASE1 Results posted Last updated 3 July 2024

What this trial tests

EARLY_PHASE1 trial testing Companion in Exercise in 51 participants. Completed in 13 December 2022.

Timeline

16 March 2021

Primary endpoint
2 November 2022

13 December 2022

Quick facts

Lead sponsor	Northeastern University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	51
Start date	16 March 2021
Primary completion	2 November 2022
Estimated completion	13 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Companion

Conditions studied

• Exercise — all drugs for Exercise →
• Physical Activity — all drugs for Physical Activity →

Sponsor

Northeastern University

Who can join

Adults 60 to 90, any sex, with Exercise or Physical Activity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline Primary · Baseline

Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.

Group	Value	95% CI
Control	1.3	± 0.5
Treatment	1.6	± 0.5

Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months Primary · 4 months

Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.

Group	Value	95% CI
Control	1.5	± 0.2
Treatment	1.5	± 0.2

Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months Primary · 6 months

Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.

Group	Value	95% CI
Control	1.5	± 0.24
Treatment	1.5	± 0.24

Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline Primary · Baseline

Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.

Group	Value	95% CI
Control	10.6	± 2.0
Treatment	10.2	± 2.0

Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months Primary · 4 months

Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.

Group	Value	95% CI
Control	10.4	± 1.9
Treatment	9.6	± 1.9

Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months Primary · 6 months

Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior.

Group	Value	95% CI
Control	10.3	± 1.8
Treatment	10.2	± 1.7

Percent Body Fat Measured Via Bioelectrical Impedance at Baseline Secondary · Baseline

This is an exploratory outcome. The amount of fat in the body will be computed as a percentage

Group	Value	95% CI
Control	38.9	± 5.8
Treatment	41.1	± 5.8

Percent Body Fat Measured Via Bioelectrical Impedance After 4 Months Secondary · 4 months

This is an exploratory outcome. The amount of fat in the body will be computed as a percentage

Group	Value	95% CI
Control	38.2	± 5.6
Treatment	40.5	± 5.6

Percent Body Fat Measured Via Bioelectrical Impedance After 6 Months Secondary · 6 months

This is an exploratory outcome. The amount of fat in the body will be computed as a percentage

Group	Value	95% CI
Control	37.7	± 5.2
Treatment	40.5	± 5.1

Attention and Executive Function Measured Using the NIH Tool Box Measured at Baseline Secondary · Baseline

This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

Group	Value	95% CI
Control	36.2	± 25.3
Treatment	42.4	± 25.3

Attention and Executive Function Measured Using the NIH Tool Box After 4 Months Secondary · 4 months

This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

Group	Value	95% CI
Control	46.0	± 25.1
Treatment	52.2	± 25.5

Attention and Executive Function Measured Using the NIH Tool Box Secondary · 6 months

This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance.

Group	Value	95% CI
Control	50.3	± 23.2
Treatment	55.3	± 23.8

Sponsor's own description

This pilot study is a small sample (N=46) 16-week clinical trial with a follow-up after 24-weeks among sedentary adults \>60 y with a BMI \>25 kg/m2 to tests the impact of a hybrid artificial intelligence behavior change system (Companion) on physical activity. Participants will be randomized to a control and intervention group. All participants will engage in a proven supervised exercise program from week 1 to 16. Only the intervention group will receive Companion from week 1 to 16.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Companion: A Pilot Randomized Clinical Trial to Test an Integrated Two-Way Communication and Near-Real-Time Sensing System for Detecting and Modifying Daily Inactivity among Adults >60 Years-Design and Protocol.
   Arguello D, Rogers E, Denmark GH, Lena J, et al · · 2023 · cited 1× · PMID 36850822 · DOI 10.3390/s23042221