Trial Outcomes & Findings for Exercise and Arterial Stiffness in Systemic Lupus Erythematosus (NCT NCT03107442)

NCT ID: NCT03107442

Last Updated: 2024-08-22

Results Overview

Pulse wave velocity assessed with Mobil-OGraph ® 24h pulse wave analysis monitor (IEM GmbH, Stolberg, Germany)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: value at 12 weeks minus value at baseline
• Results posted on: 2024-08-22

Participant Flow

Participant milestones

Measure	Exercise 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control Usual care, with recommendations for a healthy lifestyle.
Overall Study STARTED	26	32
Overall Study COMPLETED	18	28
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise and Arterial Stiffness in Systemic Lupus Erythematosus

Baseline characteristics by cohort

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.	Total n=58 Participants Total of all reporting groups
Age, Continuous	43.0 years STANDARD_DEVIATION 15.1 • n=5 Participants	44.8 years STANDARD_DEVIATION 13.1 • n=7 Participants	44.0 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	32 Participants n=7 Participants	58 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
Region of Enrollment Spain	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Body Mass Index (BMI)	25.9 kg/m^2 STANDARD_DEVIATION 3.4 • n=5 Participants	24.7 kg/m^2 STANDARD_DEVIATION 5.6 • n=7 Participants	25.2 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants

PRIMARY outcome

Timeframe: value at 12 weeks minus value at baseline

Pulse wave velocity assessed with Mobil-OGraph ® 24h pulse wave analysis monitor (IEM GmbH, Stolberg, Germany)

Outcome measures

Measure	Exercise n=22 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=28 Participants Usual care, with recommendations for a healthy lifestyle.
Arterial Stiffness	-0.26 m/s Standard Error 0.14	-0.22 m/s Standard Error 0.13

SECONDARY outcome

Timeframe: Change from baseline to week 12

High sensitivity C-Reactive Protein (hs-CRP)

Outcome measures

Measure	Exercise n=22 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=28 Participants Usual care, with recommendations for a healthy lifestyle.
Markers of Inflammation	0.17 mg/L Standard Error 0.59	-0.24 mg/L Standard Error 0.55

SECONDARY outcome

Timeframe: Change from baseline to week 12

Blood glucose levels

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Glucose	-3.12 mg/dL Standard Error 0.69	4.47 mg/dL Standard Error 3.77

SECONDARY outcome

Timeframe: Change from baseline to week 12

Blood insulin levels

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Insulin	-0.32 microUI/mL Standard Error 0.09	0.30 microUI/mL Standard Error 0.16

SECONDARY outcome

Timeframe: Change from baseline to week 12

Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Homeostasis Model Assessment of Insulin Resistance	-0.1 HOMA Index Standard Error 0.03	0.22 HOMA Index Standard Error 0.07

SECONDARY outcome

Timeframe: Change from baseline to week 12

Glycated hemoglobin (HbA1c %) obtained from blood sample

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Glycated Hemoglobin	-0.02 percentage hemoglobin Standard Error 0.003	0.10 percentage hemoglobin Standard Error 0.02

SECONDARY outcome

Timeframe: Change from baseline to week 12

Triglycerides

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Lipid	-2.72 mg/dL Standard Error 1.86	3.5 mg/dL Standard Error 0.62

SECONDARY outcome

Timeframe: Change from baseline to week 12

Assessed by the modified Bruce Test on a treadmill. The test comprised five increasing workload stages of 3 min each (stage 1: 2.7 km/h and 10% inclination; stage 2: 4 km/h and 12% inclination; stage 3: 5.5 km/h and 14% inclination; stage 4: 6.8 km/h and 16% inclination; stage 5: 8 km/h and 18% inclination). The test concluded when the participant achieved 85% of the individual's HRmax

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Cardiorespiratory Fitness	2.622 minutes Standard Error 0.41	0.43 minutes Standard Error 0.45

SECONDARY outcome

Timeframe: Change from baseline to week 12

Assessed by isometric handgrip dynamometry (hand grip strength test [TKK 5401, Takei Scientific Instruments, Tokyo, Japan]

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Muscle Strength	0.91 Kg Standard Error 0.33	0.27 Kg Standard Error 0.07

SECONDARY outcome

Timeframe: Change from baseline to week 12

Assessed by the back scratch test (from the Senior Fitness Test battery)

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Flexibility	-0.03 cm Standard Error 0.13	-2.66 cm Standard Error 0.05

SECONDARY outcome

Timeframe: Change from baseline to week 12

Waist and hip circumferences (cm) and ratio

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Waist and Hip Circumference	0.03 Waist to hip ratio Standard Error 0.2	0.02 Waist to hip ratio Standard Error 0.006

SECONDARY outcome

Timeframe: Change from baseline to week 12

Body Mass Index

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
BMI	0.3 kg/m^2 Standard Error 0.03	0.51 kg/m^2 Standard Error 0.10

SECONDARY outcome

Timeframe: Change from baseline to week 12

Fibrinogen in Blood

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Coagulation	29.23 mg/dL Standard Error 13.99	38.1 mg/dL Standard Error 10.03

SECONDARY outcome

Timeframe: Change from baseline to week 12

Creatinine in blood sample

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Renal Function	0.01 mg/dL Standard Error 0.10	-0.08 mg/dL Standard Error 0.03

SECONDARY outcome

Timeframe: Change from baseline to week 12

The Spanish version of the 36-item Short-Form Health Survey (SF-36) was used to assess HRQoL. This questionnaire is validated for patients with SLE and it assesses eight health dimensions that define two global domains: the physical and mental component scales (PCS and MCS, respectively). Only the global domains were used for the present work, which scores range from 0 (worst possible health status) to 100 (the best possible health status).

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Health-related Quality of Life	3.82 points Standard Error 2.07	0.21 points Standard Error 1.63

SECONDARY outcome

Timeframe: Change from baseline to week 12

Assessed by the Beck Depression Inventory second edition (BDI-II). Depressive symptomatology was assessed through the Beck Depression Inventory-second edition (BDI-II) [41]. This questionnaire has been used extensively in research, including SLE . It is a 21-item self-report measure where, according to how patients felt during the past 2 weeks, each depressive symptom is rated from 0 (not present) to 3 (severe). The BDI-II provides an overall score (0-63) where higher score indicates higher depressive symptomatology.

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Depression	-3.32 score on a scale Standard Error 1.74	-1.32 score on a scale Standard Error 1.56

SECONDARY outcome

Timeframe: Change from baseline to week 12

Fatigue was assessed with the Multidimensional Fatigue Inventory (MFI), which is a well-established instrument previously used in SLE. This questionnaire includes 5 subscales of fatigue severity: general, physical, and mental fatigue as well as reduced activity, and reduced motivation. Each subscale consists of four items ranging from 4 to 20, with higher scores indicating greater fatigue on that subscale.

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Fatigue	-3 units on a scale Standard Error 0.74	-0.01 units on a scale Standard Error 0.66

SECONDARY outcome

Timeframe: Change from baseline to week 12

Sleep quality over the last month interval was assessed with the Pittsburg Sleep Quality Index (PSQI), a widely-used instrument in SLE. This questionnaire is composed of 19 questions addressing a variety of factors related to sleep quality. The sleep quality global score is the sum of all components, that ranges from 0 to 21, with higher scores indicating worse sleep quality.

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Sleep Quality	-0.96 units on a scale Standard Error 0.84	-0.32 units on a scale Standard Error 0.65

SECONDARY outcome

Timeframe: Change from baseline to week 12

Assessed by the Sedentary Behavior Questionnaire (SBQ). Assesses the amount of time spent on nine different behaviours.

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Sedentary Behavior	129 min/week Standard Error 3.67	105 min/week Standard Error 10.83

SECONDARY outcome

Timeframe: Change from baseline to week 12

Adherence to the Mediterranean diet was estimated using the Mediterranean Diet Score. It consists of 11 items including whole grains, fruits, vegetables, potatoes, legumes, fish, poultry, dairy products (such as cheese, yogurt, and milk), red meats and their derivatives, olive oil, and red wine. Based on the portions the patients had consumed, the foods were scored from 0 to 5 (according to their position in the Mediterranean Diet pyramid). Total score ranges from 0 to 55, where higher scores indicate higher adherence to the Mediterranean diet and greater diet quality.

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Adherence to the Mediterranean Diet	-1.61 score on a scale Standard Error 0.01	0.71 score on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Change from baseline to week 12

Assessed by the Perceived Stress Scale (PSS). Psychological stress was measured with the Perceived Stress Scale (PSS), a 14-item self-report global measure designed to assess the degree to which situations in one's life are appraised as stressful [35]. The PSS have shown to be a valid and reliable measure in patients with SLE [36]. According to how patients felt during the last month, each item is rated from 0 (never) to 4 (very often). The PSS provides a single overall score (0-56) where higher score represents greater perceived stress.

Outcome measures

Measure	Exercise n=26 Participants 12-weeks aerobic exercise intervention Aerobic exercise: 12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous \[40-85% of the individual's heart rate reserve\] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.	Control n=32 Participants Usual care, with recommendations for a healthy lifestyle.
Perceived Stress	-1.6 units on a scale Standard Error 1.13	-1.2 units on a scale Standard Error 1.00

Adverse Events

Exercise

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

Dr José Antonio Vargas-Hitos

FIBAO

Phone: 625943933

Email: joseantoniovh@hotmail.com

Results disclosure agreements

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