Trial Outcomes & Findings for The Back Exercises to Neutralize Disability Study (NCT NCT02308189)
NCT ID: NCT02308189
Last Updated: 2018-06-19
Results Overview
The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by MRI at week 10 (study day 70) after start of exercise training.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Baseline and following 10-weeks of exercise training. Values are calculated from % change.
Results posted on
2018-06-19
Participant Flow
Participant milestones
| Measure |
Exercise
Low load resistance exercise training
Exercise: Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs.
|
Exercise With Blood Flow Restriction
Low load resistance exercise training with blood flow restriction
Exercise with blood flow restriction: Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two subjects withdrew after randomization. Analysis completed on 30 subjects
Baseline characteristics by cohort
| Measure |
Exercise
n=17 Participants
Low load resistance exercise training
Exercise: Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs.
|
Exercise With Blood Flow Restriction
n=15 Participants
Low load resistance exercise training with blood flow restriction
Exercise with blood flow restriction: Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants • Two subjects withdrew after randomization. Analysis completed on 30 subjects
|
0 Participants
n=14 Participants • Two subjects withdrew after randomization. Analysis completed on 30 subjects
|
0 Participants
n=30 Participants • Two subjects withdrew after randomization. Analysis completed on 30 subjects
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants • Two subjects withdrew after randomization. Analysis completed on 30 subjects
|
14 Participants
n=14 Participants • Two subjects withdrew after randomization. Analysis completed on 30 subjects
|
30 Participants
n=30 Participants • Two subjects withdrew after randomization. Analysis completed on 30 subjects
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants • Two subjects withdrew after randomization. Analysis completed on 30 subjects
|
0 Participants
n=14 Participants • Two subjects withdrew after randomization. Analysis completed on 30 subjects
|
0 Participants
n=30 Participants • Two subjects withdrew after randomization. Analysis completed on 30 subjects
|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 10.3 • n=17 Participants
|
28.4 years
STANDARD_DEVIATION 9.2 • n=15 Participants
|
29.2 years
STANDARD_DEVIATION 9.5 • n=32 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=17 Participants
|
10 Participants
n=15 Participants
|
20 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=17 Participants
|
5 Participants
n=15 Participants
|
12 Participants
n=32 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=17 Participants
|
15 Participants
n=15 Participants
|
32 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: Baseline and following 10-weeks of exercise training. Values are calculated from % change.Population: Per protocol analysis of completed study participants
The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by MRI at week 10 (study day 70) after start of exercise training.
Outcome measures
| Measure |
Exercise
n=16 Participants
Low load resistance exercise training
Exercise: Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs.
|
Exercise With Blood Flow Restriction
n=14 Participants
Low load resistance exercise training with blood flow restriction
Exercise with blood flow restriction: Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises.
|
|---|---|---|
|
Trunk Extensor Muscle Cross Sectional Area % of Change
|
-1.7 percentage of change
Standard Deviation 1.0
|
-3.9 percentage of change
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline and following 10-weeks of exercise training. Values calculated are % of changePopulation: Study participants completing study.
Maximal muscle strength
Outcome measures
| Measure |
Exercise
n=16 Participants
Low load resistance exercise training
Exercise: Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs.
|
Exercise With Blood Flow Restriction
n=14 Participants
Low load resistance exercise training with blood flow restriction
Exercise with blood flow restriction: Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises.
|
|---|---|---|
|
Muscle Strength % of Change
|
8.4 percentage of change from baseline
Standard Deviation 3.1
|
4.7 percentage of change from baseline
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline and following 10-weeks of exercise training. Values are calculated on % of change.Population: Study participants completing study.
Time for successfully performing a sustained, submaximal muscle contraction
Outcome measures
| Measure |
Exercise
n=16 Participants
Low load resistance exercise training
Exercise: Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs.
|
Exercise With Blood Flow Restriction
n=14 Participants
Low load resistance exercise training with blood flow restriction
Exercise with blood flow restriction: Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises.
|
|---|---|---|
|
Muscle Endurance (Time to Task Failure) % of Change
|
25.1 percentage of change from baseline
Standard Deviation 4.9
|
21.0 percentage of change from baseline
Standard Deviation 5.1
|
Adverse Events
Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise With Blood Flow Restriction
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