Trial Outcomes & Findings for Preventing the Loss of Muscle and Function in Hospitalized Older Adults (NCT NCT02566590)

Last Updated: 2019-04-23

Results Overview

Thigh lean mass (grams) will be measured by DEXA scan at baseline and after 5-days of bed rest. The change in thigh lean mass will be calculated between these two time points. This outcome will be measured for the Control and the NMES + PRO groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline and after 5-days of Bed rest

Results posted on

2019-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Control Participants will complete bed rest but will receive a non-protein placebo supplement non-protein placebo supplement: supplement will be used as a placebo to control participants. The supplement will be provided 3x a day during bed rest.	NMES + PRO Participants will receive daily treatment with neuromuscular electrical stimulation (NMES) and daily supplements of a protein drink. NMES: device is used to stimulate muscle contraction in the legs of the patient. The intervention will be used 3 times a day during bed rest. Protein: supplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during bed rest.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventing the Loss of Muscle and Function in Hospitalized Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=10 Participants Participants will complete bed rest but will receive a non-protein placebo supplement non-protein placebo supplement: supplement will be used as a placebo to control participants. The supplement will be provided 3x a day during bed rest.	NMES + PRO n=10 Participants Participants will receive daily treatment with neuromuscular electrical stimulation (NMES) and daily supplements of a protein drink. NMES: device is used to stimulate muscle contraction in the legs of the patient. The intervention will be used 3 times a day during bed rest. Protein: supplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during bed rest.	Total n=20 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	69 years STANDARD_DEVIATION 6.7 • n=5 Participants	69 years STANDARD_DEVIATION 5.4 • n=7 Participants	69 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 5-days of Bed rest

Outcome measures

Outcome measures
Measure	Control n=10 Participants Participants will complete bed rest but will receive a non-protein placebo supplement non-protein placebo supplement: supplement will be used as a placebo for control participants. The supplement will be provided 3x a day during bed rest.	NMES + PRO n=10 Participants Participants will receive daily treatment with neuromuscular electrical stimulation (NMES) and daily supplements of a protein drink. NMES: device is used to stimulate muscle contraction in the legs of the patient. The intervention will be used 3 times a day during each day of bed rest. Protein (PRO): supplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during each day of bed rest.
The Percent Change in Bilateral Thigh Lean Mass Density (Grams) as Measured by DEXA Scan Will be Compared Between Baseline and After 5-days of Bed Rest	-3.845 Percent Change Standard Error 0.883	-0.249 Percent Change Standard Error 1.189

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NMES + PRO

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

Micah Drummond

University of Utah

Phone: 8015877764

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place