Resistance Exercise in Rheumatic Disease

NCT01599260 | Terminated

• 1 other identifier: NA_00069415
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

People with rheumatic disease often have decreased strength, muscle mass, and bone mineral density due to repeated bouts of inflammation, normal effects of aging, disuse, and inactivity. The medications used to quell the disease process, such as prednisone, can also have detrimental effects on body composition, strength, and functional capacity. The investigators propose to investigate the feasibility, safety, and effects of resistance exercise in older patients with rheumatoid arthritis (RA) and vasculitis. The unique resistance protocol the investigators propose involves performing movements in a slow and controlled fashion (i.e., no acceleration or use of momentum in the lifting and lowering of the resistance) to minimize force on the joints and connective tissues. This will be conducted in an individually-supervised environment with a new generation of exercise equipment that will accommodate their musculoskeletal capabilities and allow for reproducibility of the exercise protocol. The investigators intend to investigate the feasibility, safety, musculoskeletal, and psychological effects of this resistance exercise protocol in older patients with rheumatoid arthritis and vasculitis by testing their strength, body composition, functional ability, mood, and quality of life before and after this 16-week resistance exercise intervention.

Conditions

Rheumatoid Arthritis; Systemic Vasculitis

Outcome Measures

Primary Outcomes (2)

• Number of participants with rheumatoid arthritis flares during the study

  Participants will be provided with questionnaires. They will be asked to report the number of arthritis flares since the last visit. Arthritis flares consist of pain and swelling of the joints. The total number of flares during the 16 week study will be reported.

  up to 16 weeks

• Number of participants with reported physical injuries during the study

  Participants will be provided with questionnaires. They will be asked to report the number of injuries associated with the last visit (e.g. strains, sprains, and pulled muscles). The total number of injuries during the 16 week study will be reported.

  up to 16 weeks

Secondary Outcomes (6)

• Change in Body composition after 16 weeks of resistance exercise

  16 weeks

• Change in Strength after 16 weeks of resistance exercise

  16 weeks

• Change in Functional status after 16 weeks of resistance exercise

  16 weeks

• Change in inflammatory cytokine Interleukin-6 (IL6) after 16 weeks of resistance exercise

  16 weeks

• Change in inflammatory cytokine C-reactive protein (CRP) after 16 weeks of resistance exercise

  16 weeks

Study Arms (1)

Resistance Exercise

EXPERIMENTAL

Subjects will participate in a 16 week long resistance exercise program which will consist of 2 30-minute individually supervised sessions per week.

Other: Resistance Exercise

Interventions

Resistance Exercise OTHER

Two 30-minute individually supervised exercise sessions per week for 16-weeks

Resistance Exercise

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of rheumatoid arthritis OR systemic vasculitis (defined as granulomatosis with polyangiitis, Churg-Strauss, microscopic polyangiitis, Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, or giant cell arteritis)

You may not qualify if:

• Non-English speaking
• Pregnancy
• Absolute cardiac or pulmonary contraindication to exercise
• pacemaker

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Campus

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Systemic Vasculitis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rebecca L Manno, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 15, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

US (1)