Aerobic Exercise in Women With Systemic Lupus Erythematosus

NCT03186794 | Terminated Results

• 2 other identifiers: 17011117-CC-0111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Background: As many as 1.5 million Americans are living with systemic lupus erythematosus (Lupus). Lupus makes people very tired. It also makes it hard for people to be physically active. Studies have shown that aerobic exercise training helps people with heart or lung illnesses be less tired and more active. Researchers want to use an exercise training program on people with Lupus to see if it has the same results. Objectives: To find out if aerobic exercise helps people with Lupus be less tired and more active. Eligibility: Women ages 21-80 who have Lupus and are not physically active. Design: Participants will be screened with a medical history and physical exam. They will have heart and lung tests, as well as blood and urine tests. They will also answer questions about their quality of life and take a test that measures lupus activity. The study will last 14-16 weeks. For the first two study visits, participants will do treadmill exercise tests and answer more quality of life questions. For these treadmill tests, participants will wear sensors, a mask, or a mouthpiece while they exercise. Participants will then begin exercise training, 3 times a week for 12 weeks. At each of these visits, they will walk very fast for 30 minutes on a track or a treadmill. Each visit will last about 1 hour. At the halfway point of the study, participants will repeat some of the screening tests. This visit will last about 3 hours. At the end of the study, participants will repeat the screening tests. They will also repeat the treadmill exercise tests.

Conditions

Systemic Lupus Erythematosus; Lupus; Autoimmune Disease; Rheumatic Disease

Keywords

Rehabilitation; Fatigue

Outcome Measures

Primary Outcomes (4)

• Change in the Time Taken to Attain the Anaerobic Threshold (AT)

  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).

  Before 12-week intervention (Pre) and after 12-week intervention (Post)

• Change in the Time Constant for Oxygen Uptake Kinetics

  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).

  Before 12-week intervention (Pre) and after 12-week intervention (Post)

• Change in Performance Fatigability Index (PerfFI)

  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).

  Before 12-week intervention (Pre) and after 12-week intervention (Post)

• Change in Perceived Fatigability Index (PercFI)

  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).

  Before 12-week intervention (Pre) and after 12-week intervention (Post)

Secondary Outcomes (13)

• Change in Muscle Oxygenation

  Before 12-week intervention (Pre) and after 12-week intervention (Post)

• Change in Cardiac Function

  Before 12-week intervention (Pre) and after 12-week intervention (Post)

• Change in Fatigue Severity Scale (FSS)

  Before 12-week intervention (Pre) and after 12-week intervention (Post)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Anxiety Domain

  Before 12-week intervention (Pre) and after 12-week intervention (Post)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Depression Domain

  Before 12-week intervention (Pre) and after 12-week intervention (Post)

Study Arms (1)

Aerobic exercise training (AET)

EXPERIMENTAL

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 \[0.7 to 0.8 \* (peak heart rate - resting heart rate) + resting heart rate\]

Other: Treadmill exercise training

Interventions

Treadmill exercise training OTHER

30 minutes of continuous treadmill walking at a target intensity or use of an interval approach in which walking at the target will be sustained at smaller training interval durations of no shorter than 5 minutes followed by an active rest interval that is no longer than 1.5 times the training interval until the subject achieves a total exercise time of 30 minutes, excluding the rest intervals. Each session will last about 60 minutes but slightly longer if an interval approach is used.

Aerobic exercise training (AET)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfilling 4 of the 11 American College of Rheumatology Criteria for the Classification of Systemic Lupus Erythematosus
• Age 21 to 80
• Female Gender
• BMI less than 40

You may not qualify if:

• SELENA-SLEDAI score less than or equal to 4, maintained for at least three months. (C3 and C4 levels are measured as markers for stability and included in the SELENA-SLEDAI score if abnormal).
• No increase in doses of immunosuppressive medications (hydroxychloroquine, mycophenolate mofetil, azathioprine, methotrexate) for at least three months at the time of screening.
• No increase in the dose of prednisone or equivalent steroid in the past 3 months at the time of screening.
• Physically inactive, not participating in aerobic exercise training at heart rate above 60% maximum heart rate, 20 min/session or more, 2 or more days per week, within the last 6 months at the time of screening.
• Fatigue Severity Scale (FSS) composite score greater than or equal to 3 indicating the presence of clinically significant fatigue
• Subjects must be able to walk on a treadmill
• Prednisone greater than or equal to 15 mg daily (or equivalent)
• Have started azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide or biologics within 3 months
• Rituximab infusion within 6 months
• Present symptoms of ischemic heart disease, right- or left-sided heart failure, cor pulmonale or pulmonary hypertension, dilated or hypertrophic cardiomyopathy or non- idiopathic cardiomyopathy
• Significant pulmonary dysfunction (obstructive, restrictive, or infectious pulmonary disease)
• Significant hepatic (LFT \> 2 times of upper limit of normal) or renal dysfunction (GFR\<45 ml/min)
• Deep vein thrombosis
• Chronic anticoagulation (with the exception of low dose aspirin) or a history of a bleeding disorder
• History or presence of any form of cancer other than skin cancer or cervical in-situ cancer

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Keyser RE, Rus V, Cade WT, Kalappa N, Flores RH, Handwerger BS. Evidence for aerobic insufficiency in women with systemic Lupus erythematosus. Arthritis Rheum. 2003 Feb 15;49(1):16-22. doi: 10.1002/art.10926.

  PMID: 12579589 BACKGROUND

• Keyser RE, Rus V, Mikdashi JA, Handwerger BS. Exploratory study on oxygen consumption on-kinetics during treadmill walking in women with systemic lupus erythematosus. Arch Phys Med Rehabil. 2010 Sep;91(9):1402-9. doi: 10.1016/j.apmr.2010.06.003.

  PMID: 20801259 BACKGROUND

• Carvalho MR, Sato EI, Tebexreni AS, Heidecher RT, Schenkman S, Neto TL. Effects of supervised cardiovascular training program on exercise tolerance, aerobic capacity, and quality of life in patients with systemic lupus erythematosus. Arthritis Rheum. 2005 Dec 15;53(6):838-44. doi: 10.1002/art.21605.

  PMID: 16342102 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases; Rheumatic Diseases; Fatigue

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Musculoskeletal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Leighton Chan
• Organization: Clinical Center

chanle@cc.nih.gov

+1 301 496 4733

Study Officials

• Leighton Chan, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 14, 2017
• Study Start: February 22, 2018
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: May 10, 2022
• Results First Posted: May 10, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication of results.
• Access Criteria: Permission of PI and approval from the IRB prior to any research use of stored de-identified samples beyond the scope of this study.

Locations

US (1)