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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strategy training for physical activity | Experimental | 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. |
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| Physical activity | Active Comparator | 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. |
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| Education | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strategy training for physical activity | Behavioral | STPA is a home-based rehabilitation that guides stroke participants to implement strategy training for addressing barriers to physical activity engagements. Participants learn and practice meta-cognitive strategies (to set a goal, to make a plan, to do the plan, to check the performance of the plan) throughout the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Trail-Making Test, Part B (TMT-B) | 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. | 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-word condition (SCWT-CW) | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | MoCA with 30 items evaluates the cognitive functions (range 0 to 30). This assessment covers domains such as visuospatial/executive skills, naming, memory, attention, language, abstraction, delayed recall, and orientation. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) | NIHSS is used to assess participants' stroke severity during the study period (range 0 to 42). | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Tzu Chi Hospital | New Taipei City | 231 | Taiwan | |||
| Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The allocation ratio is 1:1:1.
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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.
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| Physical activity | Behavioral | PA program consists of a warm-up for 5 minutes, an aerobic exercise program for 30-40 minutes, a multicomponent exercise program (resistance and balance training) for 10-20 minutes, and finally, a cooling down program for 5 minutes. |
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| Education | Other | Stroke-related information and knowledge that includes stroke subtypes and their etiology, risk factors of primary and secondary stroke, healthy lifestyles, common sequala, and adaptive skills for impaired functions are provided. |
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| Trail-Making Test, Part A (TMT-A) | The TMT-A requires participant to orderly trace the numeral stimuli as quickly and accurately as possible, and shorter time to complete represent better performance (maximum 300 seconds) | 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) | The SCET-C asks participant to correctly answer the color ink in accordance with word on the cards, and greater correct responses denoting better performance. | 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 | This assessment comprises six standardized questions indicating three factors: awareness, readiness to change, and strategy behavior. | 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 | The AM-PAC measures the difficulty is performing three activity domains: Basic Mobility (18 activities), Daily Activity (15 activities), and Applied Cognition (19 activities) on a 4-point scale. In this trial, Applied Cognition domain is viewed as a secondary outcome. | 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) | PM-3D4D consists of 24 items for evaluating three domains of participation, which are community, productivity, and social. Participants will be asked to rate all items on the four distinct dimensions: (1) diversity, (2) frequency, (3) desire for change, and (4) perceived difficulty. | 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) | During the test, participants are asked to complete a serous of tasks: standing up from a chair, walking straight for 3 meters, turning around, walking back to the chair, and sitting down. The time to complete is recorded. | 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 | IPAQ is used to calculate MET-minute per week based on participants' self-report physical activity durations on walking, moderate exercise, and vigorous exercise in the nearest 7 days. | 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) |
| modified Rankin Scale (mRS) |
mRS is used to indicate participants' global disability during the study period (range 0 to 6). |
| 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) |
| Fugl-Meyer Assessment (FMA) | FMA is used to quantify participants' motor impairment of upper and lower limb during the study period (range 0 to 100). | 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) |
| Saltin-Grimby Physical Activity Level Scale (SGPALS) | SGPALS is used to indicate participants' level of physical activity during the study period (range 1 to 6). | 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) |
| Stroke Self-Efficacy Questionnaire (SSEQ) | SSEQ is used to evaluate participants' self-efficacy during the study period. | 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) |
| EQ-5D-3L | EQ-5D-3L is used to evaluate participants' health-related quality of life during the study period. | 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) |
| Hospital Anxiety and Depression Scale (HADS) | HADS is used to measure participants' mood status during the study. | 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) |
| New Taipei City |
| 235 |
| Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Medical University Hospital | Taipei | 110 | Taiwan |
| Taipei Municipal Wanfang Hospital | Taipei | 116 | Taiwan |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |