Trial Outcomes & Findings for Chronic Kidney Disease Among Frail Elderly (NCT NCT02351349)
NCT ID: NCT02351349
Last Updated: 2021-05-26
Results Overview
the entire sample will be followed until time of death or until study completed. The cause of death will be determined from proxies or from hospital records.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
6 months
Results posted on
2021-05-26
Participant Flow
For recruitment 14 were consented 5 patients dropped out -- 3 started hemodialysis the first week of starting the study and 2 due to medical illness and desire not to follow up with testing
Participant milestones
| Measure |
Intervention: Multi Intervention
Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support
multidisciplinary intervention: multidisciplinary intervention
|
Control
These individuals did not receive exercise advice and did not see the dietician unless there was a clinical problem
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Intervention: Multi Intervention
Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support
multidisciplinary intervention: multidisciplinary intervention
|
Control
These individuals did not receive exercise advice and did not see the dietician unless there was a clinical problem
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Chronic Kidney Disease Among Frail Elderly
Baseline characteristics by cohort
| Measure |
Multidisciplinary Intervention
n=4 Participants
Due to the problem of randomization, the study became a before and after assessment in the one group that completed the 12 week exercise program and received nutritional support
multidisciplinary intervention: multidisciplinary intervention
|
Control
n=5 Participants
Those who were offered the program but did not complete the prescription
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
76.5 years
n=99 Participants
|
78 years
n=107 Participants
|
78 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Weight
|
67 kilograms
n=99 Participants
|
74 kilograms
n=107 Participants
|
73 kilograms
n=206 Participants
|
|
height
|
1.64 meters
n=99 Participants
|
1.63 meters
n=107 Participants
|
1.63 meters
n=206 Participants
|
|
Body mass index
|
27.2 kg/m^2
n=99 Participants
|
29.2 kg/m^2
n=107 Participants
|
28.2 kg/m^2
n=206 Participants
|
|
estimated GFR
|
32 ml/min/1.73m^2
n=99 Participants
|
17 ml/min/1.73m^2
n=107 Participants
|
31 ml/min/1.73m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: mortality
the entire sample will be followed until time of death or until study completed. The cause of death will be determined from proxies or from hospital records.
Outcome measures
| Measure |
Intervention: Multi Intervention
n=4 Participants
Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support
multidisciplinary intervention: multidisciplinary intervention
|
Control
n=5 Participants
those who were randomized to no exercise program
|
|---|---|---|
|
Mortality
|
0 percentage of mortality
|
0 percentage of mortality
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: three individuals started hemodialysis within 1 week of randomization, they were excluded
Number of patients progressed to the need for renal replacement therapy (any modality or palliation).
Outcome measures
| Measure |
Intervention: Multi Intervention
n=4 Participants
Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support
multidisciplinary intervention: multidisciplinary intervention
|
Control
n=5 Participants
those who were randomized to no exercise program
|
|---|---|---|
|
Number of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: no hospitalizations recorded in either arm
information about principal diagnosis, number and length of hospitalizations will be collected at 6-month intervals from participant, from proxies
Outcome measures
| Measure |
Intervention: Multi Intervention
n=4 Participants
Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support
multidisciplinary intervention: multidisciplinary intervention
|
Control
n=5 Participants
those who were randomized to no exercise program
|
|---|---|---|
|
Hospitalizations
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: data on 4m walk, time up and go, dominant hand grip
assessed by applying the data of the 4 meter walk compared between the two study groups.
Outcome measures
| Measure |
Intervention: Multi Intervention
n=4 Participants
Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support
multidisciplinary intervention: multidisciplinary intervention
|
Control
n=5 Participants
those who were randomized to no exercise program
|
|---|---|---|
|
Physical Functioning Measures
baseline 4 m walk
|
5 seconds
Interval 3.3 to 7.0
|
5.3 seconds
Interval 4.3 to 5.8
|
|
Physical Functioning Measures
4m walk at 12 weeks
|
3.9 seconds
Interval 2.6 to 6.0
|
5.5 seconds
Interval 4.2 to 6.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: time up and go
one of the physical functioning parameters
Outcome measures
| Measure |
Intervention: Multi Intervention
n=4 Participants
Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support
multidisciplinary intervention: multidisciplinary intervention
|
Control
n=5 Participants
those who were randomized to no exercise program
|
|---|---|---|
|
Time up and go
baseline
|
12 seconds
Interval 8.6 to 17.5
|
13 seconds
Interval 11.1 to 14.4
|
|
Time up and go
12 weeks
|
10.8 seconds
Interval 6.9 to 15.8
|
13.3 seconds
Interval 11.3 to 15.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: paired t test
right hand grip average of three values
Outcome measures
| Measure |
Intervention: Multi Intervention
n=4 Participants
Due to the problem of randomization, the study became a before and after assessment in the one group that completed the exercise program and received nutritional support
multidisciplinary intervention: multidisciplinary intervention
|
Control
n=5 Participants
those who were randomized to no exercise program
|
|---|---|---|
|
Dominant Hand Grip
baseline
|
23 kg
Interval 14.0 to 35.0
|
19 kg
Interval 16.0 to 23.0
|
|
Dominant Hand Grip
12 weeks
|
26.5 kg
Interval 14.0 to 39.0
|
20 kg
Interval 16.0 to 28.0
|
Adverse Events
Intervention: Multi Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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