Clinical trial NCT06790173: Effects of Strategy Training for Physical Activity (STPA) on the Post-stroke Executive Dysfunction
Official title: Effects of Strategy Training for Physical Activity on Executive Functions in Stroke Survivors With Cognitive Impairments: a Phase II Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Keywords: Stroke
Executive function
Strategy training
Physical activity
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The allocation ratio is 1:1:1.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. 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;
2. Examine the potential association between improvements in executive functions resulting from STPA and enhancements in activity and participation performance;
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Trail-Making Test, Part B (TMT-B)
timeFrame: 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: Stroop Color and Word Test, color-word condition (SCWT-CW)
timeFrame: 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)
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 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: Trail-Making Test, Part A (TMT-A)
timeFrame: 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: Stroop Color and Word Test, color condition (SCWT-C)
timeFrame: 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: Self-Regulation Skills Interview
timeFrame: 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: Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms
timeFrame: 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: Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: 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: Time-Up and Go test (TUG)
timeFrame: 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: International Physical Activity Questionnaire (IPAQ) short form
timeFrame: 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)
Other outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 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: modified Rankin Scale (mRS)
timeFrame: 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: Fugl-Meyer Assessment (FMA)
timeFrame: 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: Saltin-Grimby Physical Activity Level Scale (SGPALS)
timeFrame: 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: Stroke Self-Efficacy Questionnaire (SSEQ)
timeFrame: 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: EQ-5D-3L
timeFrame: 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: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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)
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
Study officials:
References: