Trial Outcomes & Findings for Home-based Exercise Via a Telecommunications System (NCT NCT00248781)

NCT ID: NCT00248781

Last Updated: 2014-01-10

Results Overview

The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 103 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2014-01-10

Participant Flow

Participant milestones

Measure	Automated Exercise Group Telecommunications system for exercise	Attention Control Group attention control (health education)
Overall Study STARTED	52	51
Overall Study COMPLETED	42	47
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home-based Exercise Via a Telecommunications System

Baseline characteristics by cohort

Measure	Arm 1 n=52 Participants Telecommunications system for exercise	Arm 2 n=51 Participants attention control (health education)	Total n=103 Participants Total of all reporting groups
Age, Continuous	70.3 years STANDARD_DEVIATION 7.5 • n=5 Participants	71.7 years STANDARD_DEVIATION 7.2 • n=7 Participants	71 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	51 participants n=7 Participants	103 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: number of subjects completing 6 month evaluations

The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system

Outcome measures

Measure	Automated Exercise Group n=45 Participants Telecommunications system for exercise	Attention Control Group n=48 Participants attention control (health education)
Knee Extension Strength	20.4 kg Standard Deviation 0.59	19.5 kg Standard Deviation 0.65

PRIMARY outcome

Timeframe: 6 months

Population: Number of subjects completing 6 month evaluations

The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system

Outcome measures

Measure	Automated Exercise Group n=45 Participants Telecommunications system for exercise	Attention Control Group n=48 Participants attention control (health education)
Knee Flexion Strength	34.3 kg Standard Deviation 0.76	32.2 kg Standard Deviation 0.77

PRIMARY outcome

Timeframe: 6 months

Population: The number of subjects completing 6 month evaluations

Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.

Outcome measures

Measure	Automated Exercise Group n=45 Participants Telecommunications system for exercise	Attention Control Group n=48 Participants attention control (health education)
Single Leg Stance With Eyes Open	20.9 s Standard Deviation 1.30	17.4 s Standard Deviation 1.30

PRIMARY outcome

Timeframe: 6 months

Population: The number of subjects completing 6 month evaluations

Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.

Outcome measures

Measure	Automated Exercise Group n=45 Participants Telecommunications system for exercise	Attention Control Group n=48 Participants attention control (health education)
Tandem Stance	54.8 s Standard Deviation 1.9	50.5 s Standard Deviation 2.35

PRIMARY outcome

Timeframe: 6 months

Population: The number of subjects completing 6 month evaluations

Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.

Outcome measures

Measure	Automated Exercise Group n=45 Participants Telecommunications system for exercise	Attention Control Group n=48 Participants attention control (health education)
Six-minute Walk	450.6 m Standard Deviation 5.09	449.8 m Standard Deviation 5.22

SECONDARY outcome

Timeframe: 12 months

The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system

Outcome measures

Measure	Automated Exercise Group n=42 Participants Telecommunications system for exercise	Attention Control Group n=47 Participants attention control (health education)
Knee Extension Strength (Durability)	20.3 kg Standard Deviation 0.71	19.4 kg Standard Deviation 0.66

SECONDARY outcome

Timeframe: 12 months

The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system

Outcome measures

Measure	Automated Exercise Group n=42 Participants Telecommunications system for exercise	Attention Control Group n=47 Participants attention control (health education)
Knee Flexion Strength (Durability)	34.5 kg Standard Deviation 0.81	32.5 kg Standard Deviation 0.82

SECONDARY outcome

Timeframe: 12 months

Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.

Outcome measures

Measure	Automated Exercise Group n=42 Participants Telecommunications system for exercise	Attention Control Group n=47 Participants attention control (health education)
Single Leg Stance With Eyes Open (Durability)	20.1 s Standard Deviation 1.35	16.6 s Standard Deviation 1.39

SECONDARY outcome

Timeframe: 12 months

Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.

Outcome measures

Measure	Automated Exercise Group n=42 Participants Telecommunications system for exercise	Attention Control Group n=47 Participants attention control (health education)
Tandem Stance (Durability)	55.8 s Standard Deviation 2.18	51.6 s Standard Deviation 2.38

SECONDARY outcome

Timeframe: 12 months

Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.

Outcome measures

Measure	Automated Exercise Group n=42 Participants Telecommunications system for exercise	Attention Control Group n=47 Participants attention control (health education)
Six-minute Walk (Durability)	446.8 m Standard Deviation 4.77	446.1 m Standard Deviation 4.91

Adverse Events

Automated Exercise Group

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

Attention Control Group

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Automated Exercise Group n=52 participants at risk Telecommunications system for exercise	Attention Control Group n=51 participants at risk attention control (health education)
Cardiac disorders stroke	1.9% 1/52 • Number of events 1 • 12 months	2.0% 1/51 • Number of events 1 • 12 months
Cardiac disorders atrial fibrillation	1.9% 1/52 • Number of events 1 • 12 months	0.00% 0/51 • 12 months
Cardiac disorders bypass surgery	0.00% 0/52 • 12 months	2.0% 1/51 • Number of events 1 • 12 months
Surgical and medical procedures kidney surgery	1.9% 1/52 • Number of events 1 • 12 months	2.0% 1/51 • Number of events 1 • 12 months
Surgical and medical procedures knee replacement surgery	1.9% 1/52 • Number of events 1 • 12 months	2.0% 1/51 • Number of events 1 • 12 months
Surgical and medical procedures total hip replacement surgery	0.00% 0/52 • 12 months	2.0% 1/51 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders wrist injury	1.9% 1/52 • Number of events 1 • 12 months	0.00% 0/51 • 12 months
Musculoskeletal and connective tissue disorders hand and rib injury	1.9% 1/52 • Number of events 1 • 12 months	0.00% 0/51 • 12 months
Musculoskeletal and connective tissue disorders torn cartilage in knee	0.00% 0/52 • 12 months	2.0% 1/51 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders bronchitis	0.00% 0/52 • 12 months	2.0% 1/51 • Number of events 1 • 12 months

Other adverse events

Measure	Automated Exercise Group n=52 participants at risk Telecommunications system for exercise	Attention Control Group n=51 participants at risk attention control (health education)
Musculoskeletal and connective tissue disorders Inury/discomfort	15.4% 8/52 • Number of events 8 • 12 months	13.7% 7/51 • Number of events 7 • 12 months

Additional Information

Dr. David Sparrow

VA Boston Healthcare System

Phone: 857-364-6407

Email: david.sparrow@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place