Effects of Strategy Training for Physical Activity on Executive Functions in Stroke Survivors With Cognitive Impairments: a Phase II Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Trail-Making Test, Part B (TMT-B)
研究概览
简要总结
The goal of this randomized controlled trial is to examine if combining strategy training and physical activity (STPA) works to improve executive function in community-dwelling adults with post-stroke cognitive impairment. The main questions it aims to answer are:
- Does STPA and physical exercise alone lead to greater improvements in executive function among stroke survivors relative to the control intervention with education?
- Does STPA outperform physical exercise alone in the efficacy of executive functions?
- Do the effects of STPA on executive functions transfer to the global cognition, balance, and activity-participation outcomes?
- Do the effects of STPA persist for at least 6 months post-intervention?
Researchers will compare the efficacy of the STPA intervention against physical exercise alone or control intervention with education.
Participants will:
receive STPA, physical activity only, or an education program 2 to 3 sessions per week until finishing 12 sessions.
be assessed clinical outcomes at 5 times: pre-intervention, post-intervention, 3-month, 6-month, and 12-month follow-up.
详细描述
Poststroke cognitive impairment is a prevalent consequence of stroke that significantly impacts multifaceted outcomes. Executive functions are particularly responsive to training among cognitive domains. Despite the accumulating literature supporting physical activity interventions, their effects have been observed to be small and time-limited. Incorporating a behavioral approach, such as strategy training, offers a promising avenue for promoting improvements in executive functions and related stroke outcomes. To the best of investigators' understanding, no study has examined whether combining strategy training with physical activity-oriented goals can ameliorate executive and cognitive functions in individuals with stroke.
This study aims to examine and compare the efficacy of STPA and physical activity alone on executive, cognitive, activity, and participation functions in people with poststroke cognitive impairments. This study addresses the following specific aims:
- Determine whether STPA in stroke patients with PSCI produces immediate improvements in executive functions that may generalize to improved global cognition, activity, or participation outcomes to a greater extent than a control intervention focused on stroke-related education;
- Examine the potential association between improvements in executive functions resulting from STPA and enhancements in activity and participation performance;
- Investigate the duration of therapeutic effects of STPA following the intervention;
To achieve these aims, a three-armed, parallel-design, randomized phase II clinical trial is designed and conducted. The investigators plan to recruit an expected sample of 120 adults with poststroke cognitive impairments from collaborative sites in northern Taiwan. Eligible participants are randomly assigned to one of the three intervention groups (STPA, physical activity, and education) at a 1:1:1 ratio. All participants should receive 12 sessions lasting 60 minutes over a maximum of 6 weeks. Primary outcomes for executive functions (Trail Making Test Part B and color-word condition of Stroop Color and Word Test) and secondary outcome measures, including Montreal Cognitive Assessment, processing speed (Trail Making Test Part A and word condition of Stroop Color and Word Test), Self-Regulation Skills Interview, Activity Measure for Post-Acute Care Outpatient Short Forms, Participation Measure-3 Domains, 4 Dimensions, Timed-Up and Go test, and Taiwan version of the International Physical Activity Questionnaire are administered at baseline (T1), post-intervention (T2), and 3-month (T3), 6-month (T4), and 12-month (T5) follow-ups. Data will be analyzed using constrained longitudinal data analysis and mixed-effects regression models. Additionally, qualitative in-depth interviews will be conducted with participants, caregivers, and therapists to understand their experiences, satisfaction, and their perceived effectiveness of the intervention. Transcribed data will be coded and analyzed with thematic analysis method.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
A researcher is responsible for the randomization process and the results are coded with predefined IDs that investigators and outcomes assessors are unaware of the meaning.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years old
- •A diagnosis of stroke within the past 3 year
- •Speaking Mandarin
- •Montreal Cognitive Assessment (maximum=30) < 26
- •14 item-Executive Interview > 3
- •Willing to provide informed consent
排除标准
- •Modified Rankin Scale (mRS) = 5
- •Any conditions that may impede the participation in the study, such as severe aphasia, postoperative immobilization, or major neuropsychiatric diseases.
- •Pre-stroke mRS >1
- •6-level Saltin-Grimby Physical Activity Level Scale (SGPALS) = 5 or 6
- •Participating in other interventional study concurrently
研究组 & 干预措施
Strategy training for physical activity
Trained therapists visit each participant for 60 minutes twice or thrice a week. The program consists of 12 therapist-guided sessions over a maximum of 6 weeks and includes the following active ingredients: knowledge of physical activity, self-selected activity-based goals, dynamic performance analysis, global strategy ("Goal-PlanDo-Check"), and guided discovery.
干预措施: Strategy training for physical activity (Behavioral)
Physical activity
Participants assigned to the PA group receive a protocol of exercise program with 12, 1-hour sessions in total. Similar to STPA group, the frequency of intervention is twice or thrice a week.
干预措施: Physical activity (Behavioral)
Education
Participants in this group receive a dose-matched educational intervention with 12 visits by well-trained research therapists through face-to-face talks. Sessions focus on instruction on general information regarding stroke and rehabilitation, and a summary of participants' condition and progression is provided for each visit.
干预措施: Education (Other)
结局指标
主要结局
Trail-Making Test, Part B (TMT-B)
时间窗: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
The TMT-B is a time-limited test (maximum 300 seconds) requiring participant to orderly trace stimuli that alternated between encircles numbers and characters as quickly and accurately as possible, with shorter time denoting better cognitive flexibility.
Stroop Color and Word Test, color-word condition (SCWT-CW)
时间窗: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
The Stroop Color and Word Test involves counting correct numbers according to a rule. In color-word condition, the word (e.g. "Red") is printed in a different color ink (e.g. green ink), while participants will require to name the color of ink, with greater correct responses denoting better inhibition.
次要结局
- Montreal Cognitive Assessment (MoCA)(5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5))
- Trail-Making Test, Part A (TMT-A)(5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5))
- Stroop Color and Word Test, color condition (SCWT-C)(5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5))
- Self-Regulation Skills Interview(5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5))
- Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms(5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5))
- Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)(5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5))
- Time-Up and Go test (TUG)(5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5))
- International Physical Activity Questionnaire (IPAQ) short form(5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5))
研究者
Feng-Hang Chang
Professor
Taipei Medical University