Trial Outcomes & Findings for Telemedicine Intervention to Improve Physical Function (NCT NCT01639469)

Results Overview

Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

169 participants

Primary outcome timeframe

up to 1 year

Results posted on

2017-06-23

Participant milestones
Measure	Structured Exercise Structured exercise instruction by smartphone Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises.	Lifestyle Exercise Lifestyle exercise program taught via smartphone Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies
Overall Study STARTED	89	80
Overall Study COMPLETED	84	77
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal
Measure	Structured Exercise Structured exercise instruction by smartphone Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises.	Lifestyle Exercise Lifestyle exercise program taught via smartphone Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies
Overall Study Death	4	2
Overall Study Lost to Follow-up	1	1

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Structured Exercise n=89 Participants Structured exercise instruction by smartphone Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises.	Lifestyle Exercise n=80 Participants Lifestyle exercise program taught via smartphone Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies	Total n=169 Participants Total of all reporting groups
Age, Continuous	71.5 years STANDARD_DEVIATION 9.4 • n=89 Participants	72.7 years STANDARD_DEVIATION 9.8 • n=80 Participants	72.1 years STANDARD_DEVIATION 9.6 • n=169 Participants
Sex: Female, Male Female	2 Participants n=89 Participants	2 Participants n=80 Participants	4 Participants n=169 Participants
Sex: Female, Male Male	87 Participants n=89 Participants	78 Participants n=80 Participants	165 Participants n=169 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

Timeframe: up to 1 year

Population: 2 participants not analyzed were excluded due to "early loss to follow-up" and had no fall data collected.

Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.

Outcome measures
Measure	Structured Exercise n=88 Participants Structured exercise instruction by smartphone Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises.	Lifestyle Exercise n=79 Participants Lifestyle exercise program taught via smartphone Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies
Total Falls During the 1-year Follow-up	1026 Total count of falls	1861 Total count of falls

Serious events: 4 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events
Measure	Structured Exercise n=89 participants at risk Structured exercise instruction by smartphone Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises.	Lifestyle Exercise n=80 participants at risk Lifestyle exercise program taught via smartphone Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies
General disorders Death	4.5% 4/89 • Number of events 4 • Adverse events were collected over 1 year participation period.	2.5% 2/80 • Number of events 2 • Adverse events were collected over 1 year participation period.

Adverse event data not reported

VA Boston Healthcare System

Phone: 857-364-6407