Trial Outcomes & Findings for Lower Extremity Muscle and Function in the Elderly: Study 2 (NCT NCT01614392)

NCT ID: NCT01614392

Last Updated: 2018-12-10

Results Overview

Leg extensor muscle power measured on pneumatic strength testing equipment at a external force consistent with 70% of the participant maximum leg extensor strength.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: Change from baseline to Week 16
• Results posted on: 2018-12-10

Participant Flow

Participant milestones

Measure	High Velocity Low Force Power Training Lower extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).	Low Velocity High Force Power Training Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
Overall Study STARTED	25	27
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	High Velocity Low Force Power Training n=25 Participants Lower extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).	Low Velocity High Force Power Training n=27 Participants Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).	Total n=52 Participants Total of all reporting groups
Age, Continuous	78.3 years STANDARD_DEVIATION 5 • n=25 Participants	77.6 years STANDARD_DEVIATION 4 • n=27 Participants	77.9 years STANDARD_DEVIATION 4.5 • n=52 Participants
Sex: Female, Male Female	15 Participants n=25 Participants	18 Participants n=27 Participants	33 Participants n=52 Participants
Sex: Female, Male Male	10 Participants n=25 Participants	9 Participants n=27 Participants	19 Participants n=52 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Change from baseline to Week 16

Population: 4 participants dropped out of study before follow up

Leg extensor muscle power measured on pneumatic strength testing equipment at a external force consistent with 70% of the participant maximum leg extensor strength.

Outcome measures

Measure	Power Training Performed at Low External Resistance n=24 Participants High velocity low force power training performed at low external resistance (40% of the 1repetition maximum strength (RM)\[LO\]	Power Training Performed at High External Resistance n=24 Participants Low velocity high force power training performed at high external resistance (70% of the 1 repetition maximum (RM) \[HI\])
Leg Extensor Muscle Power	32.9 Watts Standard Error 13	41.6 Watts Standard Error 12

Adverse Events

High Velocity Low Force Power Training

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Low Velocity High Force Power Training

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	High Velocity Low Force Power Training n=25 participants at risk Lower extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).	Low Velocity High Force Power Training n=27 participants at risk Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
Infections and infestations General	4.0% 1/25 • 4 months	11.1% 3/27 • 4 months
Musculoskeletal and connective tissue disorders Musculoskeletal	0.00% 0/25 • 4 months	3.7% 1/27 • 4 months
Respiratory, thoracic and mediastinal disorders Pulmonary	0.00% 0/25 • 4 months	3.7% 1/27 • 4 months

Additional Information

Dr. Roger Fielding

Jean Mayer USDA HNRCA, Tufts University

Phone: 6175563083

Email: Roger.Fielding@tufts.edu

Results disclosure agreements

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