Trial Outcomes & Findings for Blood Flow and Bone Density in Healthy Adult Women (NCT NCT00397462)

Results Overview

Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

One year

Results posted on

2016-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Low Use requested that they use the intervention during only the morning or afternoon up to 4 hours	Group 2 High Use requested that they use the intervention as much as possible during the work day	Control No intervention
Overall Study STARTED	16	13	15
Overall Study COMPLETED	16	13	15
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blood Flow and Bone Density in Healthy Adult Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Low Use n=16 Participants requested that they use the intervention during only the morning or afternoon up to 4 hours	Group 2 High Use n=13 Participants requested that they use the intervention as much as possible during the work day	Control n=15 Participants No use of the intervention	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	44 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	47.9 years STANDARD_DEVIATION 8.1 • n=5 Participants	44.8 years STANDARD_DEVIATION 9.1 • n=7 Participants	44.5 years STANDARD_DEVIATION 8.1 • n=5 Participants	45.8 years STANDARD_DEVIATION 7.9 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	16 participants n=5 Participants	13 participants n=7 Participants	15 participants n=5 Participants	44 participants n=4 Participants

PRIMARY outcome

Timeframe: One year

Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Control n=15 Participants No change to usual behavior	Low Dose n=16 Participants Request that calf muscle pump stimulation be used less than four hours per day calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart	High Dose n=13 Participants Request that calf muscle pump stimulation be used at least four hours per day calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart
Bone Density of Proximal Femur	-0.133 percent change in bone density Standard Error .370	-.675 percent change in bone density Standard Error .437	1.3 percent change in bone density Standard Error 0.382

SECONDARY outcome

Timeframe: One year

Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Control n=15 Participants No change to usual behavior	Low Dose n=16 Participants Request that calf muscle pump stimulation be used less than four hours per day calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart	High Dose n=13 Participants Request that calf muscle pump stimulation be used at least four hours per day calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart
Proximal Tibia Bone Density	1.14 percent change in bone density Standard Error 1.14	-2.111 percent change in bone density Standard Error .64	1.65 percent change in bone density Standard Error .56

Adverse Events

Group 1 Low Use

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 High Use

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Kenneth McLeod

Binghamton University, SUNY

Phone: (607)777-5779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place