Trial Outcomes & Findings for A Study of Muscle Strength Maintenance in Older Adults (NCT NCT01989793)

NCT ID: NCT01989793

Last Updated: 2018-06-12

Results Overview

Isokinetic Strength was measured by knee extension exercises where bilateral knee concentric strength was measured using a Biodex System 3 dynamometer set at an angular velocity of 30deg/sec through a joint arc from 90 degrees to 30 degrees (0 degrees- full extension). The change in strength between baseline and week 8 (i.e., baseline minus week 8) was the outcome of the analysis. A negative number indicates that there was a decrease in isokinetic strength from week 0 to week 8.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: Baseline to Week 8
• Results posted on: 2018-06-12

Participant Flow

Participant milestones

Measure	Losartan For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Overall Study STARTED	18	19
Overall Study COMPLETED	10	15
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Muscle Strength Maintenance in Older Adults

Baseline characteristics by cohort

Measure	Losartan n=18 Participants For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=19 Participants For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm	Total n=37 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
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
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	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	15 Participants n=7 Participants	29 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

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.

Isokinetic Strength was measured by knee extension exercises where bilateral knee concentric strength was measured using a Biodex System 3 dynamometer set at an angular velocity of 30deg/sec through a joint arc from 90 degrees to 30 degrees (0 degrees- full extension).

The change in strength between baseline and week 8 (i.e., baseline minus week 8) was the outcome of the analysis. A negative number indicates that there was a decrease in isokinetic strength from week 0 to week 8.

Outcome measures

Measure	Losartan n=10 Participants For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=15 Participants For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Change From Baseline in Isokinetic Strength	-4.90 Newton Standard Deviation 11.76	-4.73 Newton Standard Deviation 8.81

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.

Isokinetic Strength was measured by knee extension exercises where bilateral knee concentric strength was measured using a Biodex System 3 dynamometer set at an angular velocity of 30deg/sec through a joint arc from 90 degrees to 30 degrees (0 degrees- full extension).

The change in strength between baseline and week 16 (i.e., baseline minus week 16) was the outcome of the analysis. A negative number indicates decrease in strength from week 0 to week 16.

Outcome measures

Measure	Losartan n=10 Participants For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=15 Participants For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Change From Baseline in Isokinetic Strength	-7.40 Newton Standard Deviation 9.56	-4.27 Newton Standard Deviation 11.54

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.

Isokinetic Strength was measured by knee extension exercises where bilateral knee concentric strength was measured using a Biodex System 3 dynamometer set at an angular velocity of 30deg/sec through a joint arc from 90 degrees to 30 degrees (0 degrees- full extension).

The change in strength between baseline and week 24 (i.e., baseline minus week 24) was the outcome of the analysis. A negative number indicates a decrease in strength from week 0 to week 24.

Outcome measures

Measure	Losartan n=10 Participants For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=15 Participants For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Change From Baseline in Isokinetic Strength	-9.20 Newton Standard Deviation 8.94	-7.00 Newton Standard Deviation 10.24

PRIMARY outcome

Timeframe: Week 8

Population: Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.

Fatiguability was tested using bilateral knee extension with an external load equal to 40% of the maximal voluntary contraction force.

Fatiguability was defined as the ratio (expressed as a percentage) of the total work in the last 3 of the 10 repetitions to the total work in the first 3 of the 10 repetitions, where the total work for n repetitions is defined as the sum of peak torque (FT-LBS) over n repetitions (i.e., last three reps/first three reps). The maximum of the two sides was used in the analysis.

Outcome measures

Measure	Losartan n=10 Participants For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=15 Participants For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Fatiguability	14.29 percentage of work Standard Deviation 9.65	7.87 percentage of work Standard Deviation 15.31

PRIMARY outcome

Timeframe: Week 16

Population: Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.

Fatiguability was tested using bilateral knee extension with an external load equal to 40% of the maximal voluntary contraction force.

Fatiguability was defined as the ratio (expressed as a percentage) of the total work in the last 3 of the 10 repetitions to that of the first 3 of the 10 repetitions, where the total work for n repetitions is defined as the sum of peak torque (FT-LBS) over n repetitions (i.e., last three reps/first three reps). The maximum of the two sides was used in the analysis.

Outcome measures

Measure	Losartan n=10 Participants For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=15 Participants For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Fatiguability	16.51 percentage of work Standard Deviation 18.92	8.77 percentage of work Standard Deviation 12.15

PRIMARY outcome

Timeframe: Week 24

Population: Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.

Fatiguability was tested using bilateral knee extension with an external load equal to 40% of the maximal voluntary contraction force.

Fatiguability was defined as the ratio (expressed as a percentage) of the total work in the last 3 of the 10 repetitions to that of the first 3 of the 10 repetitions, where the total work for n repetitions is defined as the sum of peak torque (FT-LBS) over n repetitions (i.e., last three reps/first three reps). The maximum of the two sides was used in the analysis.

Outcome measures

Measure	Losartan n=10 Participants For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=15 Participants For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Fatiguability	17.07 percentage of work Standard Deviation 15.34	9.05 percentage of work Standard Deviation 14.15

SECONDARY outcome

Timeframe: from baseline to 8 weeks

Population: Compliant completers: participants who continued treatment during the entire 24 week study. and completed the final visit at 24 weeks. 10 out of the 18 participant who were given losartan completed the study and 15 out of 19 who received the placebo participant completed the study.

Number of participants experiencing any amount of decrease in frailty score from baseline to Week 8 (i.e., improvement in frailty status)

Outcome measures

Measure	Losartan n=10 Participants For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=15 Participants For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Number of Participants Experiencing Any Amount of Decrease in Frailty	3 Participants	6 Participants

SECONDARY outcome

Timeframe: from baseline to 16 weeks

Population: Compliant completers: participants who continued treatment during the entire 24 week study. and completed the final visit at 24 weeks. 10 out of the 18 participant who were given losartan completed the study and 15 out of 19 who received the placebo participant completed the study.

Number of participants experiencing any amount of decrease in frailty score from baseline to Week 16 (i.e., improvement in frailty status)

Outcome measures

Measure	Losartan n=10 Participants For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=15 Participants For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Number of Participants Experiencing Any Amount of Decrease in Frailty	3 Participants	5 Participants

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Compliant completers: participants who continued treatment during the entire 24 week study. and completed the final visit at 24 weeks. 10 out of the 18 participant who were given losartan completed the study and 15 out of 19 who received the placebo participant completed the study.

Number of participants experiencing any amount of decrease in frailty score from baseline to Week 24 (i.e., improvement in frailty status)

Outcome measures

Measure	Losartan n=10 Participants For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=15 Participants For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Number of Participants Experiencing Any Amount of Decrease in Frailty	3 Participants	5 Participants

Adverse Events

Losartan

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Losartan n=18 participants at risk For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=19 participants at risk For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
Cardiac disorders Myocardial Infarction	5.6% 1/18 • Number of events 1 • 24 weeks	0.00% 0/19 • 24 weeks

Other adverse events

Measure	Losartan n=18 participants at risk For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm.	Placebo n=19 participants at risk For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm
General disorders Fatigue	5.6% 1/18 • Number of events 1 • 24 weeks	0.00% 0/19 • 24 weeks
Vascular disorders Hypertension	5.6% 1/18 • Number of events 1 • 24 weeks	0.00% 0/19 • 24 weeks
Metabolism and nutrition disorders Creatinine	5.6% 1/18 • Number of events 1 • 24 weeks	0.00% 0/19 • 24 weeks
Metabolism and nutrition disorders Hyperkalemia	5.6% 1/18 • Number of events 1 • 24 weeks	0.00% 0/19 • 24 weeks

Additional Information

Dr. Jeremy D. Walston, M.D. , Raymond and Anna Lublin Professor of Geriatric Medicine

Johns Hopkins University

Phone: 410-550-1003

Email: jwalston@jhmi.edu

Results disclosure agreements

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