Elsevier

Contemporary Clinical Trials

Volume 33, Issue 5, September 2012, Pages 976-982
Contemporary Clinical Trials

Improving maintenance of physical activity in older, knee osteoarthritis patients trial-pilot (IMPACT-P): Design and methods

https://doi.org/10.1016/j.cct.2012.04.012Get rights and content

Abstract

Promoting increased physical activity participation is now consistently advocated in the medical management of knee osteoarthritis (OA). Unfortunately, physical activity interventions targeting older knee OA patients are plagued by high attrition rates and poor long-term adherence. Consequently, identifying effective approaches for promoting maintenance of physical activity participation is integral for the successful behavioral management of knee OA. The present study, the Improving Maintenance of Physical Activity in Knee Osteoarthritis Pilot Trial (IMPACT-P), was a single-blind two-arm, randomized controlled pilot study designed to contrast the effects of a group-mediated cognitive behavioral (GMCB) exercise intervention with those of traditional center-based exercise therapy approach (TRAD) in older, knee OA patients. A total of 80 older adults with symptomatic knee OA were randomly assigned to GMCB or TRAD interventions. The primary outcome of the IMPACT-P study was changed in self-reported (CHAMPS questionnaire) and objectively assessed (LIFECORDER EX Plus) physical activity participation of moderate intensity or greater. Secondary outcomes include physical function, quality of life, and social cognitive variables. Outcomes were obtained at baseline, 3 month, and 12 month assessments by trial personnel blinded to participants' randomization assignment.

Discussion. Determining the comparable efficacy of the GMCB and TRAD exercise interventions in producing meaningful improvements in physical activity and OA outcomes could enhance the efficacy of implementing physical activity participation in the behavioral management of symptomatic knee OA.

Section snippets

Introduction/background

Symptomatic knee osteoarthritis (OA) is a prevalent chronic degenerative disease that acts as a primary cause of activity restriction and physical disability among older adults [1]. There is considerable evidence that inactivity, secondary to the primary OA symptoms, exacerbates pain symptoms and accelerates progression toward disability in older knee OA patients [2], [3]. Given that traditional surgical and pharmacologic treatments are associated with mixed success and adverse long-term side

Overview

The Improving Maintenance of Physical Activity in Osteoarthritis Trial-Pilot (IMPACT-P) was a two-arm, single-blind randomized controlled pilot trial designed to investigate the comparable efficacy of two exercise interventions (TRAD and GMCB exercise interventions). A total of 80 older adults with radiographic evidence of symptomatic knee OA were randomly assigned to either the GMCB (n = 40) or traditional exercise intervention (n = 40) arms. Assessments of the primary and secondary outcomes were

Discussion

The IMPACT-P trial was a single-blind, two arm randomized controlled pilot trial evaluating the comparable efficacy of traditional exercise intervention with that of a social cognitive theory-based GMCB exercise intervention for producing improvements in physical activity participation and select relevant knee OA outcomes. Although exercise is now advocated as an important component in the medical management of knee OA, challenges in successfully promoting long-term maintenance of regular

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    Support for the present study was provided by NIH/NIAMS grant # R21 AR054595.

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