title: The Group Oriented Arterial Leg Study (GOALS) to improve walking performance in patients with peripheral arterial disease.
abstract: People with lower extremity peripheral artery disease (PAD) have greater functional impairment and faster functional decline than those without PAD. We describe methods for the Group Oriented Arterial Leg Study (GOALS), an ongoing randomized controlled clinical trial designed to determine whether a Group-Mediated Cognitive Behavioral (GMCB) intervention improves functional performance in PAD participants, compared to a health education control condition. In GOALS, PAD participants were randomized to either an intervention or a health education control condition in a parallel design. Both conditions consist of weekly group sessions with other PAD participants. In the intervention, cognitive behavioral techniques are used to assist participants in setting and adhering to home-based walking exercise goals. Participants are encouraged to walk for exercise at home at least 5 days/week. In the control condition, participants receive lectures on health-related topics. After 6 months of on-site weekly sessions, participants are transitioned to telephone follow-up for another 6 months. Participants in the intervention are asked to continue home walking exercise. The primary outcome is change in six-minute walk performance between baseline and six-month follow-up. Secondary outcomes include change in six-minute walk performance at 12-month follow-up, and change in treadmill walking performance, the Walking Impairment Questionnaire, quality of life, and physical activity at six and 12-month follow-up. In conclusion, if our group-mediated cognitive behavioral intervention is associated with improved walking performance in individuals with PAD, results will have major public health implications for the large and growing number of people with PAD.
authors.affiliation: Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA. mdm608@northwestern.edu
authors.forename: Mary M
authors.initials: MM
authors.lastname: McDermott
authors.forename: Kathryn
authors.initials: K
authors.lastname: Domanchuk
authors.forename: Kiang
authors.initials: K
authors.lastname: Liu
authors.forename: Jack M
authors.initials: JM
authors.lastname: Guralnik
authors.forename: Lu
authors.initials: L
authors.lastname: Tian
authors.forename: Michael H
authors.initials: MH
authors.lastname: Criqui
authors.forename: Luigi
authors.initials: L
authors.lastname: Ferrucci
authors.forename: Melina
authors.initials: M
authors.lastname: Kibbe
authors.forename: Donald-Lloyd
authors.initials: DL
authors.lastname: Jones
authors.forename: William H
authors.initials: WH
authors.lastname: Pearce
authors.forename: Lihui
authors.initials: L
authors.lastname: Zhao
authors.forename: Bonnie
authors.initials: B
authors.lastname: Spring
authors.forename: W Jack
authors.initials: WJ
authors.lastname: Rejeski
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D005080:Exercise Test; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000150:complications / Q000503:physiopathology; D035002:Lower Extremity / Q000098:blood supply / Q000503:physiopathology; D008297:Male; D010353:Patient Education as Topic / Q000379:methods*; D058729:Peripheral Arterial Disease / Q000150:complications / Q000523:psychology* / Q000628:therapy*; D013997:Time Factors; D016138:Walking