Trial Outcomes & Findings for Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients (NCT NCT02409901)

NCT ID: NCT02409901

Last Updated: 2024-11-12

Results Overview

This will be assessed through verbal questioning on the current employment status of each participant. Overall number of participants only includes participants who were unemployed at baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 135 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-11-12

Participant Flow

Participant milestones

Measure	Exercise Rehabiliation 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control Standard clinical care only
Overall Study STARTED	93	42
Overall Study Completed Baseline Assessment	80	33
Overall Study COMPLETED	52	28
Overall Study NOT COMPLETED	41	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients

Baseline characteristics by cohort

Measure	Exercise Rehabiliation n=80 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation in addition to standard clinical care	Control n=33 Participants Standard clinical care only	Total n=113 Participants Total of all reporting groups
Age, Continuous	47.29 years STANDARD_DEVIATION 11.56 • n=5 Participants	43.18 years STANDARD_DEVIATION 11.98 • n=7 Participants	45.24 years STANDARD_DEVIATION 11.61 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	18 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	15 Participants n=7 Participants	63 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	54 Participants n=5 Participants	21 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants	33 participants n=7 Participants	113 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The count represents the number of participants who were unemployed at Baseline (excluding employed participants at baseline)

This will be assessed through verbal questioning on the current employment status of each participant.

Overall number of participants only includes participants who were unemployed at baseline.

Outcome measures

Measure	Exercise Rehabilitation n=44 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=15 Participants Standard clinical care only
Employment Status	21 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 months

This will be assessed through measures of aortic pulse wave velocity (PWV)

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Subclinical Atherosclerosis - PWV	7.16 meters/second Standard Deviation 2.31	6.06 meters/second Standard Deviation 1.96

SECONDARY outcome

Timeframe: 12 months

This will be assessed through the 6 minute walk test (6MW). The test measures the distance (in meters) patients can walk in 6 minutes.

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Functional Capacity - 6MW	418.41 Meters Standard Deviation 111.65	405.95 Meters Standard Deviation 95.79

SECONDARY outcome

Timeframe: 12 months

Muscle mass will be assessed via Dual-energy X-ray absorptiometry (DEXA).

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Body Composition - DEXA	2858.10 Gram Standard Deviation 678.12	2550.69 Gram Standard Deviation 431.37

SECONDARY outcome

Timeframe: 12 months

Estimated glomerular filtration rate (eGFR) will be measured

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Metabolic State and Kidney Function - eGFR	57.46 mL/min/1.73m^2 Standard Deviation 20.91	62.48 mL/min/1.73m^2 Standard Deviation 17.70

SECONDARY outcome

Timeframe: 12 months

The Patient Reported Outcomes Measurement Information System (PROMIS) 10 - Global Physical Health short form will be administered to all patients to assess their perception of physical health at 12 months. The scale includes a list of questions that patients rate from 1 (poor) which is a minimum value on the scale to 5 (excellent) which is the maximum value on the scale. A higher score indicates a better quality of life.

The raw scores from the questions are converted into standardized t-scores. In the U.S. general population, the t-score has a mean of 50 and a standard deviation of 10. A t-score higher than 50 indicates a better quality of life compared to the general population. The cut points for the t-score are as follows: above 58 (excellent), 50 to 58 (very good), 42 to 50 (good), 35 to 42 (fair), below 35 (poor).

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Quality of Life and Perceived Health Status - PROMIS 10 Global Physical Health Score	51.58 T-score Standard Deviation 8.30	46.60 T-score Standard Deviation 8.24

SECONDARY outcome

Timeframe: 12 months

This will be assessed through measures of carotid intima-media thickness (IMT)

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Subclinical Atherosclerosis - IMT	0.58 millimeters Standard Deviation 0.12	0.57 millimeters Standard Deviation 0.12

SECONDARY outcome

Timeframe: 12 months

This will be assessed through measures of unilateral isometric strength utilizing Biodex. This measurement is for Away Peak 75-Peak Strength

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Functional Capacity - Strength (Away)	108.02 Pounds Standard Deviation 48.15	100.01 Pounds Standard Deviation 32.44

SECONDARY outcome

Timeframe: 12 months

Physical activity is assessed through accelerometers which give scores that are measured in m/s^2

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Regular Physical Activity Using Accelerometers	16.46 m/s^2 Standard Deviation 13.54	11.75 m/s^2 Standard Deviation 9.17

SECONDARY outcome

Timeframe: 12 months

Serum creatinine levels will be measured.

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Metabolic State and Kidney Function - Serum Creatinine (SCr)	1.46 mg/dL Standard Deviation 0.50	1.37 mg/dL Standard Deviation 0.80

SECONDARY outcome

Timeframe: 12 months

The Patient Reported Outcomes Measurement Information System (PROMIS) 29 form will be administered to all patients to assess their perception of their physical function12 months. The scale includes a list of questions that patients rate from 1 (poor) which is a minimum value on the scale to 5 (excellent) which is the maximum value on the scale. A higher score indicates a better quality of life.

The raw scores from the questions are converted into standardized t-scores. In the U.S. general population, the t-score has a mean of 50 and a standard deviation of 10. A t-score higher than 50 indicates a better quality of life compared to the general population. The cut points for the t-score are as follows: above 45 (within normal limits), 45 to 40 (mild), 30 to 40 (moderate), below 30 (severe).

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Quality of Life and Perceived Health Status - PROMIS 29 Physical Function Score	48.89 T-score Standard Deviation 8.64	46.45 T-score Standard Deviation 10.12

SECONDARY outcome

Timeframe: 12 months

The Patient Reported Outcomes Measurement Information System (PROMIS) 10 - Global Mental Health short form will be administered to all patients to assess their perception of their mental health at 12 months. The scale includes a list of questions that patients rate from 1 (poor) which is a minimum value on the scale to 5 (excellent) which is the maximum value on the scale. A higher score indicates a better quality of life.

The raw scores from the questions are converted into standardized t-scores. In the U.S. general population, the t-score has a mean of 50 and a standard deviation of 10. A t-score higher than 50 indicates a better quality of life compared to the general population. The cut points for the t-score are as follows: above 56 (excellent), 48 to 56 (very good), 40 to 48 (good), 29 to 40 (fair), below 29 (poor).

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Quality of Life and Perceived Health Status - PROMIS 10 Global Mental Health Score	53.11 T-score Standard Deviation 7.95	49.53 T-score Standard Deviation 6.69

SECONDARY outcome

Timeframe: 12 months

This will be assessed through measures of unilateral isometric strength utilizing Biodex. This measurement is for Towards Peak 75-Peak Strength

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Functional Capacity - Strength (Towards)	44.53 Pounds Standard Deviation 19.3	41.61 Pounds Standard Deviation 17.62

SECONDARY outcome

Timeframe: 12 months

Pain intensity is measured using PROMIS 29 scale. The scale includes a pain intensity question that patients rate from 1 (no pain) to 10 (extreme pain). A higher score indicates higher pain level.

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Pain Intensity	1.98 units on a scale Standard Deviation 2.59	3.21 units on a scale Standard Deviation 3.02

SECONDARY outcome

Timeframe: 12 months

Waist circumference will be measured at the narrowest part of the torso (above the umbilicus and below xiphoid process) in the standing position using a tape measure

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Body Composition - Waist Circumference	45.50 Inches Standard Deviation 7.33	45.33 Inches Standard Deviation 9.01

SECONDARY outcome

Timeframe: 12 months

Body mass index is calculated as weight (kg) divided by height (m) squared

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Body Composition - Body Mass Index (BMI)	35.90 kg/m^2 Standard Deviation 8.12	35.12 kg/m^2 Standard Deviation 10.03

SECONDARY outcome

Timeframe: 12 months

Blood pressure will be measured in the supine position (lying on back) in a dimly lit room after resting for fifteen minutes.

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Systolic Blood Pressure	132.92 mmHg Standard Deviation 15.69	129.71 mmHg Standard Deviation 17.22

SECONDARY outcome

Timeframe: 12 months

Blood pressure will be measured in the supine position (lying on back) in a dimly lit room after resting for fifteen minutes.

Outcome measures

Measure	Exercise Rehabilitation n=52 Participants 12 month personalized exercise rehabilitation in addition to standard clinical care Exercise Rehabilitation: 12 month personalized exercise rehabilitation twice a week, in addition to standard clinical care	Control n=28 Participants Standard clinical care only
Diastolic Blood Pressure	80.83 mmHg Standard Deviation 10.71	82.46 mmHg Standard Deviation 9.12

Adverse Events

Exercise Rehabiliation

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

Shyreen Kamal, Director of Clinical Research

University of Illinois Chicago

Phone: 2068830173

Email: shyreen@uic.edu

Results disclosure agreements

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