A Stage 1 Pilot Test for Feasibility and Efficacy of a Multi-Level Intervention to Increase Physical Activity in Adults With Intellectual Disability: Physical Activity and Community EmPOWERment (PACE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Number of Steps Per Day as Measured by the ActiGraph GT9X Link
研究概览
简要总结
Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer's Disease (AD)/age-related dementias (ARD).
Participants: Participants include 120 adults with ID, their caregivers, and their coaches (up to 360 individual participants, grouped as triads), recruited through the University of North Carolina at Chapel Hill and the University of Arkansas. Participants also include 16 exercise professionals.
Procedures (methods): Each cohort will include 20 triads who are randomly assigned to the PACE program or the waitlist control group.
详细描述
Each potential adult with ID or family who contacts the research team will be called and screened for eligibility in the study. To determine eligibility, screening questions will include asking if the adult participant has a formal diagnosis of ID; report of intellectual ability level will be confirmed with direct cognitive testing during the screening assessment visit using scales completed by the participant and caregiver. Also at the screening visit, caregivers will complete the dementia screener for the participants, and participants will be provided with an Actigraph GT9X Link device so they can complete a weeklong physical activity baseline measure. At the second study visit, participants and caregivers will complete the pre-assessments (described below and attached), and participants will have their body composition measured. Questions to all scorable assessments will be required to prevent missing data. Select demographic information will have an additional "prefer not to answer" choice. Participants will complete demographic measures, primary and secondary outcome measures, and feasibility and acceptability measures across the first two study visits. Those who qualify will be randomly assigned to one of two conditions: (1) initial intervention or (2) waitlist control. Individuals assigned to the waitlist control group will begin the intervention after the initial group completes post-assessments.
The 16-week intervention includes: (1) a weekly group fitness class for adults with ID, (2) web based training and resources for coaches and exercise professionals; (3) weekly coaching meetings for coaches and adults with ID, and (4) daily/weekly interactions with the PACE interactive web based dashboard for adults with ID.
A post-assessment visit will be conducted to repeat the pre-assessment measures, and a subset of participants and coaches will also complete an interview to answer open-ended questions about their program experiences. A 12-month follow-up visit will also be scheduled to measure body composition again.
Brief description of measures to be completed by Caregivers as follows:
Vineland Adaptive Behavior Scales-3: (VABS) (Vineland-3) is a standardized assessment tool that utilizes semi-structured interview to measure adaptive behavior and support the diagnosis of intellectual and developmental disabilities, autism, and developmental delays. Interviews are expected to take 1-2 hours and will take place during the screening visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for adults with ID will include:
- •ages 18 and older with a prior clinical diagnosis of ID, confirmed by scores < 70 and + 90% on the Leiter-3 International Performance Scales and/or an adaptive behavior measure using the Vineland Adaptive Behavior Scales,
- •Medical clearance to participate in moderate-to-vigorous physical activity as determined by the American College of Sports Medicine (ACSM) preparticipation algorithm,
- •Adult does not show clinically elevated symptoms of Alzheimer's Disease (AD)/ Alzheimer's Disease and Related Dementias (ADRD) as indicated by a score of < 20 on the Dementia Screening Questionnaire for Individuals with Intellectual Disabilities.
- •One caregiver/guardian is able and willing to participate.
- •must tolerate at least 8 hours of daily wear-time of Actigraph device during initial assessment period (4 of 7 days),
- •must average 20 minutes or less of moderate to vigorous physical activity (MVPA) minutes per day (140 MVPA minutes or less across 7-day period measured during the initial assessment period, and
- •must reside in North Carolina or Arkansas.
排除标准
- •for adults with ID:
- •Diagnosis of AD, dementia, or related disorders. Participants will not be excluded based on gender, race, or ethnicity. There will be no upper age limit due to the heterogeneity of onset of AD/ADRD in individuals with ID.
- •Inclusion criteria for coach will include:
- •access to the internet and a mobile device,
- •has weekly contact with the adult participant with ID,
- •can converse and read in English to comprehend intervention materials and website content, and
- •must reside in North Carolina or Arkansas
- •Inclusion criteria for caregiver will include:
- •ability to converse and read in English to comprehend and answer interview questions, (2) must care for an adult with ID who is willing to participate in the study,
- •must reside in North Carolina or Arkansas, and
- •must attend all study visits with adult with ID.
研究组 & 干预措施
PACE Program
The 16-week intervention includes: (1) a weekly group fitness class for adults with ID, (2) web-based training and resources for coaches and exercise professionals; (3) weekly coaching meetings for coaches and adults with ID, and (4) daily/weekly interactions with the PACE interactive web-based dashboard for adults with ID.
干预措施: PACE Program (Behavioral)
Waitlist Control
Participants assigned to the Waitlist Control Group will not receive any intervention during this interval. Participants will receive the PACE Program after the completion of the 16-weeks for the Intervention Group.
结局指标
主要结局
Number of Steps Per Day as Measured by the ActiGraph GT9X Link
时间窗: Baseline, post-intervention (16 weeks)
The Actigraph GT9X Links measures daily step counts. Step counts less than 2500 are classified as basal, step counts between 2500 to 4999 are classified as limited, step counts between 5000 to 7499 are classified as low, step counts between 7500-9999 are classified as somewhat active, step counts between 10000 to 12499 are classified as active, and step counts over 12500 are classified as very active.
Minutes of Moderate-to-Vigorous Activity Per Day as Measured by the ActiGraph GT9X Link
时间窗: Baseline, post-intervention (16 weeks)
The Actigraph GT9X Links measures activity counts each minute of wear time. Each activity count over 3,941 equals 1 minute of moderate-vigorous physical activity. A total of 150 or more weekly MVPA minutes meets Physical Activity guideline recommendations.
次要结局
- Body Composition from Baseline as Measured by percentage of total body mass(Baseline, post-intervention (16 weeks), Follow-up (74 weeks))
- Wellbeing from Baseline as Measured by the World Health Organization Quality of Life Assessment and Disabilities Module(Baseline, post-intervention (16 weeks))
- Daily Living Skills from Baseline as Measured by the Waisman Activities of Daily Living Scale(Baseline, post-intervention (16 weeks))
- Mental and Cognitive Functioning from Baseline as Measured by the NIH-Toolbox Cognitive Battery(Baseline, post-intervention (16 weeks))
- Psychological Well-Being, and Social Relationships from Baseline as Measured by the NIH Toolbox Emotion Battery(Baseline, post-intervention (16 weeks))
- Stress and Self-Efficacy, and Negative Affect from Baseline as Measured by the NIH Toolbox Emotion Battery(Baseline, post-intervention (16 weeks))
- Grip Strength from Baseline as Measured by the Hand Dynamometer(Baseline, post-intervention (16 weeks))
- Ability to Maintain Balance from Baseline as Measured by the 4-Stage Balance Test(Baseline, post-intervention (16 weeks))
- Functional Lower Extremity Strength and Endurance from Baseline as Measured by the 30-Second Chair Stand(Baseline, post-intervention (16 weeks))
- Mobility from Baseline as Measured by the Timed Up & Go (TUG)(Baseline, post-intervention (16 weeks))
- Endurance from Baseline as Measured by the 2-Minute Walk Endurance Test(Baseline, post-intervention (16 weeks))