Trial Outcomes & Findings for Aerobic Exercise in Women With Systemic Lupus Erythematosus (NCT NCT03186794)
NCT ID: NCT03186794
Last Updated: 2022-05-10
Results Overview
The anaerobic threshold (AT) is an objective measure of fatigability, and is determined from gas exchange variables during a cardiopulmonary exercise test (CPET). The effect of exercise training was examined by the change in the time taken to attain the AT by measuring the post-exercise training value minus the pre-exercise training value. A positive value indicates improvement in fatigability and a negative value indicates no improvement or worsening in fatigability. CPET measurement was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
TERMINATED
NA
24 participants
Before 12-week intervention (Pre) and after 12-week intervention (Post)
2022-05-10
Participant Flow
24 subjects were consented. 20 subjects started the study. 2 subjects were screen failure and 2 subjects were withdrawn due to pandemic closure.
Participant milestones
| Measure |
Aerobic Exercise Training (AET)
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[(0.7 to 0.8 \* peak heart rate - resting heart rate)+ resting heart rate\]
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Aerobic Exercise Training (AET)
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[(0.7 to 0.8 \* peak heart rate - resting heart rate)+ resting heart rate\]
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal due to COVID-19 pandemic closure
|
2
|
Baseline Characteristics
Aerobic Exercise in Women With Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Aerobic Exercise Training (AET)
n=20 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[(0.7 to 0.8 \* peak heart rate - resting heart rate)+ resting heart rate\]
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-cardiopulmonary exercise testing (CPET)
The anaerobic threshold (AT) is an objective measure of fatigability, and is determined from gas exchange variables during a cardiopulmonary exercise test (CPET). The effect of exercise training was examined by the change in the time taken to attain the AT by measuring the post-exercise training value minus the pre-exercise training value. A positive value indicates improvement in fatigability and a negative value indicates no improvement or worsening in fatigability. CPET measurement was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in the Time Taken to Attain the Anaerobic Threshold (AT)
|
93.3 Seconds
Standard Deviation 82.2
|
PRIMARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-square-wave exercise test
The oxygen uptake kinetics is an objective measure of fatigability, determined from oxygen uptake measures during a square-wave exercise test. The time constant is the time taken to reach 63% of the steady state response. The effect of exercise training was examined by the change in the time constant by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in fatigability and a positive value indicates no improvement or worsening in fatigability. The square-wave exercise test was done before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in the Time Constant for Oxygen Uptake Kinetics
|
-12.6 Seconds
Standard Deviation 20.4
|
PRIMARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-10 minute walk test (10MWT)
The performance fatigability index (PerfFI) is a measure of fatigability. The PerfFI was determined during a 10-minute walk test (10MWT). The average velocity of 10MWT was divided by the average velocity achieved over the first 2.5 minutes (decline in performance), then further divided by the total distance walked on the 10MWT (an index of intensity) multiplied by 1000. The effect of exercise training was examined by the change in the PerfFI by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in fatigability and a positive value indicates no improvement or worsening in fatigability. The 10MWT measurement was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Performance Fatigability Index (PerfFI)
|
-0.12 Units on a scale
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-10 minute walk test (10MWT)
The perceived fatigability index (PercFI) is a measure of fatigability. The PercFI was determined during a 10-minute walk test (10MWT) by rating their perceive tiredness on a 7-point Likert scale after the test. The score is divided by the total distance walked on the 10MWT, multiplied by 1000. The effect of exercise training was examined by the change in the PerfFI by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in fatigability and a positive value indicates no improvement or worsening in fatigability. The 10MWT measurement was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Perceived Fatigability Index (PercFI)
|
-0.43 Units on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who performed pre- and post-NIRS measurements during the cardiopulmonary exercise testing (CPET)
Muscle oxygenation is indicated by tissue saturation index (TSI), which is the amount of oxygenated hemoglobin divided by total hemoglobin in percent. This is evaluated using near-infrared spectroscopy (NIRS) during the cardiopulmonary exercise test (CPET). Peak TSI is determined at the end of the CPET representing the lowest muscle oxygenation during volitional exercise. The effect of exercise training was examined by the change in peak TSI by measuring the post-exercise training value minus the pre-exercise training value. A negative value may indicate better muscle oxygenation capacity and a positive value may indicate no change or reduction in muscle oxygenation capacity. The CPET was performed before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Muscle Oxygenation
|
-2.2 Percentage of TSI signal
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post bioimpedance cardiography measurements with CPET
Cardiac function is indicated by cardiac output, which is the amount of blood the heart pumps in 1 minute. It is defined mathematically as the product of the heart rate and cardiac stroke volume. This is measured using bioimpedance cardiography (a non-invasive method of capturing cardiodynamic variables) during the cardiopulmonary exercise test (CPET). Peak cardiac output is determined at the end of the CPET representing the highest cardiac output during volitional exercise. The effect of exercise training was examined by the change in peak cardiac output by measuring the post-exercise training value minus the pre-exercise training value. A positive value indicates improvement in cardiac function and a negative value indicates no change or worsening in cardiac function. The CPET was performed before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Cardiac Function
|
1.3 L/min
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-Fatigue Severity Scale (FSS) questionnaire
The Fatigue Severity Scale (FSS) is a 9-item questionnaire that assesses fatigue severity on a 7-point Likert scale. The FSS score is an average of the total score for the 9-items, with a minimum of 1 and a maximum of 7. A higher FSS score indicate more fatigue severity. The effect of exercise training was examined by the change in FSS average scores by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in fatigue severity and a positive value indicates no improvement or worsening in fatigue severity. The FSS questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Fatigue Severity Scale (FSS)
|
-1.4 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-PROMIS-57 profile questionnaire
The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The anxiety domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more anxiety being measured. The effect of exercise training was examined by the change in anxiety domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in anxiety and a positive value indicates no improvement or worsening in anxiety. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Anxiety Domain
|
-3.5 T-score
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-PROMIS-57 profile questionnaire
The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The depression domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more depression being measured. The effect of exercise training was examined by the change in depression domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in depression and a positive value indicates no improvement or worsening in depression. The PROMIS-57 profile was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Depression Domain
|
-4.8 T-score
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-PROMIS-57 profile questionnaire
The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The fatigue domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate greater fatigue. The effect of exercise training was examined by the change in fatigue domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in fatigue and a positive value indicates no improvement or worsening in fatigue. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Fatigue Domain
|
-6.0 T-score
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-PROMIS-57 profile questionnaire
The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The Physical Function domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more physical function being measured. The effect of exercise training was examined by the change in physical function domain by measuring the post-exercise training value minus the pre-exercise training value. A positive value indicates improvement in physical function and a negative value indicates no improvement or worsening in physical function. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Physical Function Domain
|
3.6 T-score
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-PROMIS-57 profile questionnaire
The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The Sleep Disturbance domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more sleep disturbance being measured. The effect of exercise training was examined by the change in sleep disturbance domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in sleep disturbance and a positive value indicates no improvement or worsening in sleep disturbance. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Sleep Disturbance Domain
|
-2.4 T-score
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-PROMIS-57 profile questionnaire
The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The ability to participate in social roles and activities domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more ability to participate in social roles and activities. The effect of exercise training was examined by the change in ability to participate in social roles and activities domain by measuring the post-exercise training value minus the pre-exercise training value. A positive value indicates improvement in ability to participate in social roles and activities and a negative value indicates no improvement or worsening in ability to participate in social roles and activities. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Ability to Participate in Social Roles and Activities Domain
|
1.0 T-score
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-PROMIS-57 profile questionnaire
The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The pain interference domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more pain interference being measured. The effect of exercise training was examined by the change in pain interference domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in pain interference and a positive value indicates no improvement or worsening in pain interference. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Pain Interference Domain
|
-3.9 T-score
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who completed pre- and post-PROMIS-57 profile questionnaire
The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. Pain intensity is scored from 0 to 10, with higher scores indicating greater pain intensity. The effect of exercise training was examined by the change in pain intensity domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in pain intensity and a positive value indicates no improvement or worsening in pain intensity. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Pain Intensity Score
|
-0.9 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who were assessed for SELENA-SLEDAI at pre- and post-exercise program
SELENA-SLEDAI is a 24-item weighted index measure of disease activity at time of assessment or in the preceding 10 days. It consists of clinical and laboratory variables, with a minimum score of 0 and maximum score of 105. Higher scores represent greater disease activity. The effect of exercise training was examined by the change in SELENA-SLEDAI by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in disease activity and a positive value indicates no improvement or worsening in disease activity. The SELENA-SLEDAI was assessed once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Safety of Estrogen in Lupus Erythematosus, National Assessment Modification of Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
|
-0.2 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Before 12-week intervention (Pre) and after 12-week intervention (Post)Population: The analyses included only those subjects who were assessed for SLICC/ACR-DI at pre- and post-exercise program
SLICC/ACR-DI is a 41-item instrument used to assess damage since lupus disease onset. Clinical assessment is made in 12 different organ systems, and a sum total from all organ scales are computed. A minimum score of 0 and a maximum score of 47 is possible with higher scores indicating more damage. The effect of exercise training was examined by the change in SLICC/ACR-DI by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates no change in damage since disease onset and a positive value indicates increase in damage since disease onset. The SLICC/ACR-DI was assessed before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).
Outcome measures
| Measure |
Aerobic Exercise Training (AET)
n=16 Participants
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]
|
|---|---|
|
Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR-DI)
|
0.1 score on a scale
Standard Deviation 0.3
|
Adverse Events
Aerobic Exercise Training (AET)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aerobic Exercise Training (AET)
n=20 participants at risk
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve \[(0.7 to 0.8 \* peak heart rate - resting heart rate)+ resting heart rate\]
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
5.0%
1/20 • 23 weeks
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • 23 weeks
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • 23 weeks
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • 23 weeks
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • 23 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • 23 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
10.0%
2/20 • 23 weeks
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • 23 weeks
|
|
Cardiac disorders
Presyncope
|
5.0%
1/20 • 23 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
1/20 • 23 weeks
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • 23 weeks
|
|
General disorders
Non-cardiac chest pain
|
10.0%
2/20 • 23 weeks
|
|
General disorders
Pain
|
5.0%
1/20 • 23 weeks
|
|
Immune system disorders
Dermatitis allergic
|
5.0%
1/20 • 23 weeks
|
|
Immune system disorders
Seasonal allergy
|
5.0%
1/20 • 23 weeks
|
|
Infections and infestations
Oral pain
|
5.0%
1/20 • 23 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • 23 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
6/20 • 23 weeks
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
10.0%
2/20 • 23 weeks
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
5.0%
1/20 • 23 weeks
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
5.0%
1/20 • 23 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
1/20 • 23 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
20.0%
4/20 • 23 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
3/20 • 23 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • 23 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place