Effects of Strategy Training for Physical Activity (STPA) on the Post-stroke Executive Dysfunction

NCT ID: NCT06790173

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2030-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Strategy training for physical activity

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Physical activity

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: 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.

Interventions

Strategy training for physical activity

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.

Intervention Type: BEHAVIORAL

Physical activity

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.

Intervention Type: BEHAVIORAL

Education

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.

Intervention Type: OTHER

Other Intervention Names

STPA; PA

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng-Hang Chang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Tzu Chi Hospital

New Taipei City, , Taiwan

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Taipei Municipal Wanfang Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202405115

Identifier Type: -

Identifier Source: org_study_id