The University of Texas School of Public Health, Dallas Regional Campus, Dallas, TX 78390, United States.
Contemp Clin Trials. 2012 Mar;33(2):351-63. doi: 10.1016/j.cct.2011.10.014. Epub 2011 Nov 11.
There is growing interest in promoting health for people with disabilities, yet evidence regarding community-based interventions is sparse. This paper describes the design details of a randomized controlled trial (RCT) that will test the effectiveness of a multi-component behaviorally based, intervention to promote exercise adoption (over 6 months) and maintenance (up to one year) among wheelchair users and includes descriptive data on participant characteristics at baseline. Participants were randomly assigned to either a staff-supported intervention group or a self-guided comparison group. The primary study aim is to assess the effectiveness of the multi-component behaviorally based intervention for promoting physical activity adoption and maintenance. The RCT will also assess the physical and psychosocial effects of the intervention and the complex interplay of factors that influence the effectiveness of the intervention. Therefore, the primary outcome derives from participant reports of weekly exercise (type, frequency, duration) over 52 weeks. Secondary outcomes collected on four occasions (baseline, 3 months, 6 months, 12 months) included physiological outcomes (VO(2) peak, strength), disability-related outcomes (pain, fatigue, participation), and psychosocial outcomes (exercise self-efficacy, exercise barriers, quality of life, depression, mood). This study will provide evidence regarding the effectiveness of a multi-component behaviorally based intervention for promoting exercise adoption among people with mobility impairments that necessitate wheelchair use.
人们对于促进残疾人士健康的兴趣日益浓厚，但有关社区为基础的干预措施的证据却很少。本文描述了一项随机对照试验（RCT）的设计细节，该试验旨在测试一种基于行为的多组分干预措施对促进轮椅使用者进行锻炼（6 个月以上）和维持（长达一年）的有效性，同时还包括参与者在基线时的特征的描述性数据。参与者被随机分配到员工支持的干预组或自我指导的对照组。主要研究目的是评估基于行为的多组分干预措施在促进身体活动的采用和维持方面的有效性。RCT 还将评估干预的身体和心理社会影响以及影响干预效果的复杂因素的相互作用。因此，主要结果来自参与者在 52 周内每周的锻炼（类型、频率、持续时间）报告。在四个时间点（基线、3 个月、6 个月和 12 个月）收集的次要结果包括生理结果（VO2 峰值、力量）、与残疾相关的结果（疼痛、疲劳、参与）和心理社会结果（锻炼自我效能感、锻炼障碍、生活质量、抑郁、情绪）。这项研究将为促进需要使用轮椅的行动障碍者进行锻炼的基于行为的多组分干预措施的有效性提供证据。
