Trial Outcomes & Findings for A Personalized Health Behavior System (NCT NCT03538158)

NCT ID: NCT03538158

Last Updated: 2022-10-12

Results Overview

Higher score of VO2 max indicates more oxygen consumption during incremental exercise.

Recruitment status

COMPLETED

Study phase

Target enrollment

181 participants

Primary outcome timeframe

Baseline, 3 month follow-up and 6 month follow-up

Results posted on

2022-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Condition - Fittle Senior Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Intervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.	Control Condition - Paper and Pencil Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
Overall Study STARTED	92	89
Overall Study 12 Week Intervention Phase	82	82
Overall Study 12 Week Maintenance Phase	77	81
Overall Study COMPLETED	77	81
Overall Study NOT COMPLETED	15	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Condition - Fittle Senior Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Intervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.	Control Condition - Paper and Pencil Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
Overall Study Lost to Follow-up	13	7
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Condition - Fittle Senior n=92 Participants Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Intervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.	Control Condition - Paper and Pencil n=89 Participants Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.	Total n=181 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=87 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	0 Participants n=88 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	0 Participants n=175 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.
Age, Categorical Between 18 and 65 years	17 Participants n=87 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	17 Participants n=88 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	34 Participants n=175 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.
Age, Categorical >=65 years	70 Participants n=87 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	71 Participants n=88 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	141 Participants n=175 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.
Sex: Female, Male Female	74 Participants n=89 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	67 Participants n=87 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	141 Participants n=176 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.
Sex: Female, Male Male	15 Participants n=89 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	20 Participants n=87 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	35 Participants n=176 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=89 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	12 Participants n=88 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	24 Participants n=177 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=89 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	76 Participants n=88 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	153 Participants n=177 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=89 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	0 Participants n=88 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	0 Participants n=177 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=92 Participants	0 Participants n=89 Participants	0 Participants n=181 Participants
Race (NIH/OMB) Asian	2 Participants n=92 Participants	0 Participants n=89 Participants	2 Participants n=181 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=92 Participants	0 Participants n=89 Participants	0 Participants n=181 Participants
Race (NIH/OMB) Black or African American	13 Participants n=92 Participants	11 Participants n=89 Participants	24 Participants n=181 Participants
Race (NIH/OMB) White	72 Participants n=92 Participants	74 Participants n=89 Participants	146 Participants n=181 Participants
Race (NIH/OMB) More than one race	1 Participants n=92 Participants	3 Participants n=89 Participants	4 Participants n=181 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=92 Participants	1 Participants n=89 Participants	5 Participants n=181 Participants
VO2 Max	16.6 mL/kg/min STANDARD_DEVIATION 5.4 • n=46 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	16.8 mL/kg/min STANDARD_DEVIATION 4.9 • n=41 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	16.7 mL/kg/min STANDARD_DEVIATION 5.4 • n=87 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.
Timed Up and Go	10.5 Seconds STANDARD_DEVIATION 3 • n=56 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	10.2 Seconds STANDARD_DEVIATION 2.6 • n=50 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.	10.4 Seconds STANDARD_DEVIATION 2.8 • n=106 Participants • The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.

PRIMARY outcome

Timeframe: Baseline, 3 month follow-up and 6 month follow-up

Population: The number analyzed is different than the number of subjects in the participant flow because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19.

Higher score of VO2 max indicates more oxygen consumption during incremental exercise.

Outcome measures

Outcome measures
Measure	Intervention Condition - Fittle Senior n=46 Participants Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Intervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.	Control Condition - Paper and Pencil n=41 Participants Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
VO2 Max Baseline	16.6 mL/kg/min Standard Deviation 5.4	16.8 mL/kg/min Standard Deviation 4.9
VO2 Max 3 month follow-up	15.7 mL/kg/min Standard Deviation 4.4	18.5 mL/kg/min Standard Deviation 5.6
VO2 Max 6 month follow-up	20.2 mL/kg/min Standard Deviation 1.4	17.3 mL/kg/min Standard Deviation 2

SECONDARY outcome

Timeframe: Baseline, 3 month follow-up and 6 month follow-up

To start the TUG, you will sit in the chair with your arms resting comfortably on your lap or at your sides. The test begins when the therapist says "Go" and starts the stopwatch. You would then be timed as you rise from the chair, walk three meters, turn around, return to the chair, and sit down. The recorded time on the stopwatch is the TUG score. Measure to assess mobility. A faster time indicates a better functional performance. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.

Outcome measures

Outcome measures
Measure	Intervention Condition - Fittle Senior n=56 Participants Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Intervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.	Control Condition - Paper and Pencil n=50 Participants Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
Timed Up and Go Baseline	10.5 Seconds Standard Deviation 3	10 Seconds Standard Deviation 2.6
Timed Up and Go 3 Month Follow-Up	9.2 Seconds Standard Deviation 1.8	8.6 Seconds Standard Deviation 3.9
Timed Up and Go 6 Month Follow-Up	10 Seconds Standard Deviation 2.3	8.6 Seconds Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 month follow-up and 6 month follow-up

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Condition - Fittle Senior n=92 participants at risk Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Intervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.	Control Condition - Paper and Pencil n=89 participants at risk Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
Cardiac disorders Heart surgery	0.00% 0/92 • The 6 months the participant was enrolled in the study.	1.1% 1/89 • Number of events 1 • The 6 months the participant was enrolled in the study.
General disorders Cancer	2.2% 2/92 • Number of events 2 • The 6 months the participant was enrolled in the study.	0.00% 0/89 • The 6 months the participant was enrolled in the study.
Renal and urinary disorders Kidney Stone	1.1% 1/92 • Number of events 1 • The 6 months the participant was enrolled in the study.	0.00% 0/89 • The 6 months the participant was enrolled in the study.
Respiratory, thoracic and mediastinal disorders COVID-19	0.00% 0/92 • The 6 months the participant was enrolled in the study.	1.1% 1/89 • Number of events 1 • The 6 months the participant was enrolled in the study.
Renal and urinary disorders Kidney Infection	0.00% 0/92 • The 6 months the participant was enrolled in the study.	1.1% 1/89 • Number of events 1 • The 6 months the participant was enrolled in the study.

Other adverse events

Other adverse events
Measure	Intervention Condition - Fittle Senior n=92 participants at risk Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Intervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.	Control Condition - Paper and Pencil n=89 participants at risk Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
Musculoskeletal and connective tissue disorders Fall	4.3% 4/92 • Number of events 4 • The 6 months the participant was enrolled in the study.	2.2% 2/89 • Number of events 2 • The 6 months the participant was enrolled in the study.
Musculoskeletal and connective tissue disorders Shoulder Injury	0.00% 0/92 • The 6 months the participant was enrolled in the study.	1.1% 1/89 • Number of events 1 • The 6 months the participant was enrolled in the study.
Musculoskeletal and connective tissue disorders Back Injury	0.00% 0/92 • The 6 months the participant was enrolled in the study.	2.2% 2/89 • Number of events 2 • The 6 months the participant was enrolled in the study.

Additional Information

Chelsie Burchett

Weill Cornell Medicine

Phone: 212-746-1417

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place