Trial Outcomes & Findings for Rates of Recovery From Strenuous Exercise in Physically Active Older Adults (NCT NCT02899650)

NCT ID: NCT02899650

Last Updated: 2021-01-22

Results Overview

Rate of force development are measured by determining peak torque achieved on an isometric leg extension machine.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

After the downhill running protocol, various markers of muscle damage and muscular strength were obtained 24 hours post (the third visit), 48 hours post (the forth visit) and 72 hours post (the fifth visit).

Results posted on

2021-01-22

Participant Flow

We planned to recruit a total of 60 participants. However, we were not able to recruit older unfit adults so this group was dropped from the study. Additionally, this was a research project conducted by a visiting scholar and his departure approached quickly so the study was closed prematurely with smaller numbers in each group.

Participant milestones

Participant milestones
Measure
Young Fit
Young (18-39 yrs) people who have endurance training habit
Young Unfit
Young (18-39 yrs) people who have sedentary lifestyle
Older Fit
Older (50-80 yrs) people who have endurance training habit
Older Unfit
Older (50-80 yrs) people who have sedentary lifestyle
Overall Study
STARTED
15
10
14
0
Overall Study
COMPLETED
15
10
14
0
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rates of Recovery From Strenuous Exercise in Physically Active Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Young Fit
n=15 Participants
Young (18-39 yrs) people who have endurance training habit
Young Unfit
n=10 Participants
Young (18-39 yrs) people who have sedentary lifestyle
Older Fit
n=14 Participants
Older (50-80 yrs) people who have endurance training habit
Total
n=39 Participants
Total of all reporting groups
Age, Continuous
Age
27 years
STANDARD_DEVIATION 2 • n=5 Participants
28 years
STANDARD_DEVIATION 2 • n=7 Participants
58 years
STANDARD_DEVIATION 2 • n=5 Participants
38 years
STANDARD_DEVIATION 2 • n=4 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
6 Participants
n=7 Participants
8 Participants
n=5 Participants
19 Participants
n=4 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
20 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=5 Participants
10 Participants
n=7 Participants
13 Participants
n=5 Participants
37 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants

PRIMARY outcome

Timeframe: After the downhill running protocol, various markers of muscle damage and muscular strength were obtained 24 hours post (the third visit), 48 hours post (the forth visit) and 72 hours post (the fifth visit).

Rate of force development are measured by determining peak torque achieved on an isometric leg extension machine.

Outcome measures

Outcome measures
Measure
Young Fit
n=15 Participants
Young (18-39 yrs) people who have endurance training habit exercise: acute downhill running
Young Unfit
n=10 Participants
Young (18-39 yrs) people who have sedentary lifestyle. exercise: acute downhill running
Older Fit
n=14 Participants
Older (50-80 yrs) people who have endurance training habit exercise: acute downhill running
Rate of Force Development
Baseline
102 Nm
Standard Error 3
108 Nm
Standard Error 4
100 Nm
Standard Error 2
Rate of Force Development
24h post
97 Nm
Standard Error 3
106 Nm
Standard Error 4
100 Nm
Standard Error 3
Rate of Force Development
48h post
100 Nm
Standard Error 2
106 Nm
Standard Error 5
103 Nm
Standard Error 3
Rate of Force Development
72h post
102 Nm
Standard Error 2
105 Nm
Standard Error 4
103 Nm
Standard Error 2

SECONDARY outcome

Timeframe: After the downhill running protocol, muscle damage pain scale was measured 24 hours post (the third visit), 48 hours post (the forth visit) and 72 hours post (the fifth visit).

Pain scale on quadriceps muscle was assessed using a validated visual pain scale. The scale was on a 10-point scale (0 being absence of soreness, 10 being worst imaginable soreness).

Outcome measures

Outcome measures
Measure
Young Fit
n=15 Participants
Young (18-39 yrs) people who have endurance training habit exercise: acute downhill running
Young Unfit
n=10 Participants
Young (18-39 yrs) people who have sedentary lifestyle. exercise: acute downhill running
Older Fit
n=14 Participants
Older (50-80 yrs) people who have endurance training habit exercise: acute downhill running
Pain Scale
72h post
2.7 arbitrary scale unit from 0 to 10
Standard Error 0.5
3.2 arbitrary scale unit from 0 to 10
Standard Error 0.8
1.5 arbitrary scale unit from 0 to 10
Standard Error 0.4
Pain Scale
Baseline
0.2 arbitrary scale unit from 0 to 10
Standard Error 0.1
0.1 arbitrary scale unit from 0 to 10
Standard Error 0.1
0.0 arbitrary scale unit from 0 to 10
Standard Error 0.0
Pain Scale
24h post
3.7 arbitrary scale unit from 0 to 10
Standard Error 0.5
4.7 arbitrary scale unit from 0 to 10
Standard Error 0.6
2.4 arbitrary scale unit from 0 to 10
Standard Error 0.6
Pain Scale
48h post
4.2 arbitrary scale unit from 0 to 10
Standard Error 0.6
4.9 arbitrary scale unit from 0 to 10
Standard Error 0.7
2.7 arbitrary scale unit from 0 to 10
Standard Error 0.6

Adverse Events

Young Fit

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Young Unfit

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Older Fit

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Older Unfit

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

Koichiro Hayashi

University of Texas at Austin

Phone: 512-471-8594

Results disclosure agreements

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