Trial Outcomes & Findings for Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults (NCT NCT05484661)
NCT ID: NCT05484661
Last Updated: 2024-11-21
Results Overview
Participants will complete the Fatigue Assessment Scale questionnaire (Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
change from baseline to 8 weeks
Results posted on
2024-11-21
Participant Flow
Participant milestones
| Measure |
Exercise + BCAA
Exercise will include a 3x/wk for eight weeks. Exercise protocol is designed to provide a high-volume, moderate-intensity whole body training stimulus. BCAA will include \~7-10 g of BCAAs (100 mg/kg) daily for eight weeks.
|
Exercise + Placebo
Exercise will include a 3x/wk for eight weeks exercise protocol is designed to provide a high-volume, moderate-intensity whole body training stimulus. Placebo will include \~7-10 g of maltodextrin (100 mg/kg) daily for eight weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Exercise + BCAA
Exercise will include a 3x/wk for eight weeks. Exercise protocol is designed to provide a high-volume, moderate-intensity whole body training stimulus. BCAA will include \~7-10 g of BCAAs (100 mg/kg) daily for eight weeks.
|
Exercise + Placebo
Exercise will include a 3x/wk for eight weeks exercise protocol is designed to provide a high-volume, moderate-intensity whole body training stimulus. Placebo will include \~7-10 g of maltodextrin (100 mg/kg) daily for eight weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults
Baseline characteristics by cohort
| Measure |
Exercise + BCAA
n=10 Participants
Exercise will include a 3x/wk for eight weeks exercise protocol is designed to provide a high-volume, moderate-intensity whole body training stimulus. BCAA will include \~7-10 g of BCAAs (100 mg/kg) daily for eight weeks.
|
Exercise + Placebo
n=10 Participants
Exercise will include a 3x/wk for eight weeks exercise protocol is designed to provide a high-volume, moderate-intensity whole body training stimulus. Placebo will include \~7-10 g of maltodextrin (100 mg/kg) daily for eight weeks.
|
Total
n=20 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
71.4 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
70.0 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
70.0 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 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
|
|
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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 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
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change from baseline to 8 weeksParticipants will complete the Fatigue Assessment Scale questionnaire (Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest)
Outcome measures
| Measure |
Exercise + BCAA
n=9 Participants
Exercise will include a 3x/wk for eight weeks exercise protocol is designed to provide a high-volume, moderate-intensity whole body training stimulus. BCAA will include \~7-10 g of BCAAs (100 mg/kg) daily for eight weeks.
|
Exercise + Placebo
n=10 Participants
Exercise will include a 3x/wk for eight weeks exercise protocol is designed to provide a high-volume, moderate-intensity whole body training stimulus. Placebo will include \~7-10 g of maltodextrin (100 mg/kg) daily for eight weeks.
|
|---|---|---|
|
Fatigue
|
-5.6 change in fatigue severity score
Standard Deviation 4.0
|
-4.1 change in fatigue severity score
Standard Deviation 3.1
|
Adverse Events
Exercise + BCAA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise + Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place