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

NCT06790173 | Enrolling By Invitation

• 1 other identifier: N202405115
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Stroke

Keywords

Stroke; Executive function; Strategy training; Physical activity

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (8)

• 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)

Other Outcomes (7)

• National Institutes of Health Stroke Scale (NIHSS)

  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)

  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)

  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)

Study Arms (3)

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.

Behavioral: Strategy training for physical activity

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.

Behavioral: Physical activity

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.

Other: Education

Interventions

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.

Also known as: STPA

Strategy training for physical activity

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.

Also known as: PA

Physical activity

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.

Education

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years old
• A diagnosis of stroke within the past 3 year
• Speaking Mandarin
• Montreal Cognitive Assessment (maximum=30) \< 26
• item-Executive Interview \> 3
• Willing to provide informed consent

You may not qualify if:

• 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
• level Saltin-Grimby Physical Activity Level Scale (SGPALS) = 5 or 6
• Participating in other interventional study concurrently

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (5)

Taipei Tzu Chi Hospital

New Taipei City, 231, Taiwan

Location

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

New Taipei City, 235, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The allocation ratio is 1:1:1.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

TW (5)