Regular Swimming, Vascular Function, and Arthritis

NCT01836380 | Completed

• 1 other identifier: NOA26752611
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis #1: The investigators hypothesize that both swimming training and cycling training will demonstrate significant improvements in endothelium-mediated vasodilation and central artery compliance in this population and that there will be no difference in the magnitude of increases between the water-based and land-based exercise interventions. Hypothesis #2: The investigators hypothesize that the improvements in endothelium-dependent vasodilation and arterial compliance in response to exercise training interventions will be related to the corresponding reductions in inflammatory biomarkers. Hypothesis #3: The investigators hypothesize that both swimming exercise and cycling exercise will improve functional capacities and disease progression in middle-aged and older adults with osteoarthritis.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Central Arterial Compliance

  Central Arterial Compliance: Common carotid artery diameter will be measured from the images derived from an ultrasound machine (Philips HDI-5000, Bothel, WA) equipped with a high-resolution linear-array transducer as previously described. A longitudinal image of the cephalic portion of the common carotid artery will be acquired 1-2 cm proximal to the carotid bulb with the transducer placed at 90 degrees to the vessel. The images will be analyzed with Vascular Tools 5 image analyses software. Similarly, intima-media thickness will be measured at end diastole as previously described. The combination of ultrasound imaging of a common carotid artery with simultaneous tonometric-obtained arterial pressure waveforms from the contralateral artery permits noninvasive determination of carotid artery compliance. Arterial compliance is a function of the increase in arterial pressure and a corresponding increase in cross-sectional area.

  three months

• Inflammatory Markers

  Fasted state, venous blood samples will be obtained to assess biological markers of inflammation. Serum C-reactive protein (CRP) will be assayed using ELISA (Alpha Diagnostics; San Antonio, TX). Inflammatory cytokines including Interleukin-6 (IL-6), TNF-α, and soluble receptor 1 (sTNFR1) will be analyzed from serum samples using a multiplex assay system (Bioplex, BioRad; Hercules, CA)

  three months

• Flow-Mediated Dilatation

  Flow-Mediated Dilatation is a non-invasive method to assess vascular endothelial function as previously described. Brachial artery diameters and blood flow velocity will be measured from images derived from a Doppler ultrasound machine equipped with a high-resolution linear array transducer. A longitudinal image of the brachial artery will be acquired 5-10 cm proximal to the antecubital fossa. A blood pressure cuff will be placed on the forearm 3-5 cm distal to the antecubital fossa. The cuff will be inflated to 100 mmHg above resting systolic blood pressure for 5 minutes. After cuff deflation, ultrasound-derived measurements of the brachial artery diameters and blood velocity will be taken for 3 minutes. FMD will be calculated as a percent increase in brachial artery diameter at the post-blood flow occlusion compared with the pre-blood flow occlusion.

  three months

Secondary Outcomes (5)

• Mobility

  three month

• Muscular Strength

  three months

• Body Mass and Composition

  three months

• Self-Reported Physical Function and Pain

  three months

• Health-Related Quality of Life

  three months

Study Arms (2)

Swimming Training

EXPERIMENTAL

The swimming training will be performed at two swimming pools on the campus of The University of Texas at Austin (University Aquatic Center or Gregory Gym pool). In the first 2-3 weeks a swimming instructor will provide personalized skill feedback to the subjects in the swim training group. Subjects will swim 15-20 minutes/day at a relatively low intensity of exercise while they receive swimming skill instructions. As their overall level of fitness and exercise skill improve, the intensity and duration of exercise will increase to 40-45 minutes/day at a moderate intensity of 70-75% of maximal heart rate. Exercise training will be performed three days per week.

Behavioral: Exercise Training

Cycling Training

EXPERIMENTAL

The cycling training will be conducted in the newly-constructed Exercise Training Intervention Core-Laboratory in the Department of Kinesiology and Health Education on the University of Texas campus. In the first 2-3 weeks a cycling instructor will provide personalized skill feedback to the subjects in the cycle training group. Subjects will cycle 15-20 minutes/day at a relatively low intensity of exercise while they receive cycling skill instructions. As their overall level of fitness and exercise skill improve, the intensity and duration of exercise will increase to 40-45 minutes/day at a moderate intensity of 70-75% of maximal heart rate. Exercise training will be performed three days per week.

Behavioral: Exercise Training

Interventions

Exercise Training BEHAVIORAL

Cycling Training; Swimming Training

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All the subjects will have a radiological diagnosis of osteoarthritis according to American College of Rheumatology criteria
• Subjects will be sedentary (i.e., no regular physical activity for at least the prior 1 year)

You may not qualify if:

• Subjects with significant intima thickening,
• plaque formation, and/or characteristics of atherosclerosis.
• unstable cardiac or pulmonary diseases.
• joint replacement surgery in the previous year.
• intraarticular injection nor systemic steroids within previous 3 months.
• severe disabling co-morbidity that disallows receiving exercise therapy.
• excess alcohol use (\>21 drinks/week).
• unwillingness to perform exercise.
• fear of water.
• mental incapability

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (2)

• Alkatan M, Baker JR, Machin DR, Park W, Akkari AS, Pasha EP, Tanaka H. Improved Function and Reduced Pain after Swimming and Cycling Training in Patients with Osteoarthritis. J Rheumatol. 2016 Mar;43(3):666-72. doi: 10.3899/jrheum.151110. Epub 2016 Jan 15.

  PMID: 26773104 DERIVED

• Alkatan M, Machin DR, Baker JR, Akkari AS, Park W, Tanaka H. Effects of Swimming and Cycling Exercise Intervention on Vascular Function in Patients With Osteoarthritis. Am J Cardiol. 2016 Jan 1;117(1):141-5. doi: 10.1016/j.amjcard.2015.10.017. Epub 2015 Oct 22.

  PMID: 26541906 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 19, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

US (1)