Trial Outcomes & Findings for Rehabilitation and Exercise Training After Hospitalization (NCT NCT01508650)
NCT ID: NCT01508650
Last Updated: 2019-02-07
Results Overview
The 6 minute walk test submaximal exercise test that measures how far a participant can walk in 6 continuous minutes. Participants are instructed to walk as far as possible in 6 minutes, and are allowed to slow down and take breaks as needed due to symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
up to 3 months
Results posted on
2019-02-07
Participant Flow
Participant milestones
| Measure |
No Intervention
Usual care control group
|
Active Comparator
Multi domain rehabilitation intervention
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
15
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
No Intervention
Usual care control group
|
Active Comparator
Multi domain rehabilitation intervention
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Rehabilitation and Exercise Training After Hospitalization
Baseline characteristics by cohort
| Measure |
No Intervention
n=12 Participants
Usual care control group
|
Active Comparator
n=15 Participants
Multi domain rehabilitation intervention
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.8 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
72.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 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: up to 3 monthsThe 6 minute walk test submaximal exercise test that measures how far a participant can walk in 6 continuous minutes. Participants are instructed to walk as far as possible in 6 minutes, and are allowed to slow down and take breaks as needed due to symptoms.
Outcome measures
| Measure |
No Intervention
n=12 Participants
Usual care control group
|
Active Comparator
n=12 Participants
Multi domain rehabilitation intervention
|
|---|---|---|
|
6 Minute Walk Test
|
224 meters
Standard Error 22
|
247 meters
Standard Error 22
|
SECONDARY outcome
Timeframe: up to 3 monthsThe SPPB is a multi-component measure of physical function. The SPPB is composed of 3 components-standing balance, gait speed, and timed repeated chair rise-each scored on a scale from 0 to 4 and combined for a total score of 0 to 12. A higher score denotes better physical function.
Outcome measures
| Measure |
No Intervention
n=12 Participants
Usual care control group
|
Active Comparator
n=12 Participants
Multi domain rehabilitation intervention
|
|---|---|---|
|
SPPB (Short Physical Performance Battery)
|
6.3 units on a scale
Standard Error 0.5
|
7.4 units on a scale
Standard Error 0.5
|
Adverse Events
No Intervention
Serious events: 8 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Comparator
Serious events: 11 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Intervention
n=12 participants at risk
Usual care control group
|
Active Comparator
n=15 participants at risk
Multi domain rehabilitation intervention
|
|---|---|---|
|
Cardiac disorders
Rehospitalization
|
58.3%
7/12 • Number of events 15 • 6 months
|
46.7%
7/15 • Number of events 11 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rehospitalization
|
8.3%
1/12 • Number of events 1 • 6 months
|
20.0%
3/15 • Number of events 3 • 6 months
|
|
General disorders
Rehospitalization
|
8.3%
1/12 • Number of events 1 • 6 months
|
13.3%
2/15 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Rehospitalization
|
0.00%
0/12 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Rehospitalization
|
0.00%
0/12 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Rehospitalization
|
8.3%
1/12 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Nervous system disorders
Rehospitalization
|
0.00%
0/12 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Infections and infestations
Rehospitalization
|
8.3%
1/12 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
Other adverse events
| Measure |
No Intervention
n=12 participants at risk
Usual care control group
|
Active Comparator
n=15 participants at risk
Multi domain rehabilitation intervention
|
|---|---|---|
|
Injury, poisoning and procedural complications
ED visit
|
0.00%
0/12 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
ED visit
|
0.00%
0/12 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
General disorders
ED visit
|
16.7%
2/12 • Number of events 2 • 6 months
|
13.3%
2/15 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Urgent Care Visit
|
0.00%
0/12 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place