Effects of High Intensity Interval Training Versus Intermittent Functional Training on Cardiovascular Fitness, Physical Function and Cognition in Stroke.

NCT07274748 | Recruiting DMC

• 1 other identifier: REC/0271 Shamama Naqvi
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to determine comparative effects of High intensity interval training versus Intermittent functional training on cardiovascular fitness, physical function and cognition in stroke.

Conditions

Stroke

Keywords

Cardiorespiratory fitnss ,Cognition , Stroke

Outcome Measures

Primary Outcomes (4)

• National Institutes of Health Stroke Scale(NIHSS)

  The National Institutes of Health Stroke Scale (NIHSS) is a graded neurological examination that assesses speech, language cognition, inattention, visual field abnormalities, motor and sensory impairments, and ataxia. The scale was developed for use in acute-stroke therapy trials and has since been widely used as a standard part of the assessment in clinical trials. The National Institutes of Health Stroke Scale (NIHSS) demonstrates high reliability and validity in assessing stroke severity. Inter-rater and intra-rater reliability coefficients typically exceed 0.90, indicating consistent scoring among different clinicians and repeated assessments. The scale shows strong construct validity, correlating well with other measures like the modified Rankin Scale and predicting outcomes, as higher NIHSS scores are linked to increased mortality and disability. With a Cronbach's alpha above 0.90, the NIHSS is recognized as an effective tool for guiding treatment decisions and assessing patien

  12 weeks

• MoCA (Montreal Cognitive Assessment )

  The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal. Inter-rater Reliability (0.96) Chronbach's alpha (0.79)

  12 week

• The 6-minute walk test (6MWT) for cardiorespiratory fitness

  The 6-minute walk test (6MWT) is commonly used to measure cardiovascular fitness and overall functional capacity. The 6-Minute Walk Test (6MWT) has shown strong reliability and validity in stroke patients. Specifically, studies report intra-class correlation coefficients (ICCs) ranging from 0.85 to 0.95, indicating excellent intra- and inter-rater reliability. For validity, the 6MWT correlates well with other functional measures, such as the Barthel Index and the Fugl-Meyer Assessment, with correlation coefficients often exceeding 0.70. Additionally, it has been shown to predict outcomes such as mortality and functional independence post-stroke. These statistics underscore the test's utility in assessing exercise capacity and guiding rehabilitation efforts

  12 week

• The Timed Up and Go (TUG) test for physical function and mobility

  The Timed Up and Go (TUG) test is a reliable and valid assessment tool for mobility and fall risk in post-stroke patients, with inter-rater reliability demonstrating Intraclass Correlation Coefficients (ICCs) between 0.95 and 0.98, and intra-rater reliability ranging from 0.91 to 0.95. It shows strong construct validity, correlating well with other functional mobility measures like the Berg Balance Scale, with coefficients often exceeding r = 0.80. Additionally, the TUG effectively predicts fall risk, with sensitivity around 85% and specificity around 90%. Overall, the TUG test is essential for evaluating mobility and guiding rehabilitation in stroke care

  12 week

Study Arms (2)

Group A: High-Intensity Interval Training (HIIT)

EXPERIMENTAL

The HIIT group will engage in session of alternating high-intensity and low-intensity exercise. * Total Duration: 30-35 minutes per session * Frequency: 3 days per week (Monday, Wednesday and Friday) * Duration of program: 12 weeks * Intensity: Fastest safe walking speed or 85%-95% heart rate reserve * Exercise mode: Treadmill Session structure: 1. Warm-up 1. Activity: Light walking/jogging 2. Duration: 5 min 3. Intensity: Low intensity, 40-50% of maximum heart rate. 2. Main workout: (Interval training) 1. Repetitions: 6-10 intervals 2. Structure: High-Intensity Phase: 1. Activity: sprinting or fast running pace 2. Duration: 5 min 3. Intensity: 85-95% of maximum heart rate Recovery phase: 1. Activity: walking/slow jogging 2. Duration: 1-2 mins 3. Intensity: 50-60% of max heart rate c. Interval pattern: 5 min high intensity, followed by 1-2 min recovery. d. Total High-Intensity Duration: 4x5=20 minutes e. Total Recovery Period: 4x2=8 minutes 4. Cool Down: 1. Activity:

Other: Group A: High-Intensity Interval Training (HIIT)

Group B: Intermittent Functional Training (IFT)

EXPERIMENTAL

IFT group will engage in session of task-oriented exercises (3 different tasks per circuit) focused on improving functional ability. * Total Duration: 30 minutes/session; 6-9 circuits of 3 minutes each * Frequency: 3 days per week (Monday, Wednesday and Friday) * Duration of program: 12 weeks. * Intensity: maintain heart rate 30-50 beats per minute above resting levels. * Exercise mode: task-oriented functional exercises such as * Rolling side to side on a mat * Moving from lying to sitting and sitting to standing * Stepping and transferring from standing to the floor and back Session structure: 1. Warm-up 1. Activity: Light walking/jogging 2. Duration: 5 min 3. Intensity: Low intensity 40-50% of maximum heart rate. 2. Main workout: (IFT circuits) * Circuit 1 (3 minutes) Task 1: Rolling side to side on a mat (1 minute). Task 2: Moving from lying to sitting (1 minute). Task 3: Standing up from a chair (1 minute). Rest (30-60 seconds). * Circuit 2 (3 minutes): Task 1: Stepping onto a

Other: Group B: Intermittent Functional Training (IFT)

Interventions

Group B: Intermittent Functional Training (IFT) OTHER

IFT exercises will be performed for 3-5 days per week sessions involve 6-9 circuits of task-oriented exercises lasting about 3 minutes each, designed to enhance functional ability. Each circuit combines more demanding tasks with less intense ones to maintain heart rates 30-50 beats per minute above resting levels, achieving moderate aerobic intensity for chronic stroke survivors. Exercises are tailored to individual needs and progressively increased in difficulty, including movements like rolling, transitioning between positions, and practicing stepping and transferring

Group B: Intermittent Functional Training (IFT)

Group A: High-Intensity Interval Training (HIIT) OTHER

The intervention consists of HIIT protocol performed 3-5 days per week for a period of 12 weeks, focusing on either the fastest safe walking speed for mobility gains or maintaining 85%-95% of heart rate reserve or power output at 90%-100% VO2 peak. Each session should last 25-30 minutes, utilizing a burst-to-recovery ratio of 30 seconds of intense activity followed by 30-60 seconds to 3 minutes of recovery. Treadmills or recumbent steppers will be used, with careful monitoring of intensity to prevent potential hypotensive responses.

Group A: High-Intensity Interval Training (HIIT)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both male and female stroke patients are included.
• Unilateral stroke experienced greater than 6 months prior to enrollment
• NIHSS: National Institute of Health Stroke Scale (a score of 5 to 15 represents a moderate stroke)
• Able to walk 10 minutes over ground with assistive devices as needed without physical assistance
• Able to walk 3 minutes on the treadmill at greater than 0.3 mph with no aerobic exercise contraindications.
• Stable cardiovascular condition (American Heart Association class B)
• Not currently participating in formal rehabilitation.

You may not qualify if:

• Diagnosed cardiovascular abnormalities
• Evidence of myocardial ischemia or significant arrhythmia on stress test hospitalization for cardiac or pulmonary disease within the previous 3 months, pacemaker or implanted defibrillator
• Lower extremity (LE) claudication
• Unable to communicate with investigators or correctly answer consent comprehension questions
• Severe LE spasticity (Ashworth scale score \>2)
• LE weight-bearing pain \>4/10 on a visual analog scale.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Riphah International University

Daska Kalan, Punjab Province, 51010, Pakistan

NOT YET RECRUITING

Riphah International University

Daska Kalan, Punjab Province, 51010, Pakistan

RECRUITING

Related Publications (5)

• Fulk GD, Echternach JL, Nof L, O'Sullivan S. Clinometric properties of the six-minute walk test in individuals undergoing rehabilitation poststroke. Physiother Theory Pract. 2008 May-Jun;24(3):195-204. doi: 10.1080/09593980701588284.

  PMID: 18569856 RESULT

• Nindorera F, Nduwimana I, Sinzakaraye A, Havyarimana E, Bleyenheuft Y, Thonnard JL, Kossi O. Effect of mixed and collective physical activity in chronic stroke rehabilitation: A randomized cross-over trial in low-income settings. Ann Phys Rehabil Med. 2023 May;66(4):101704. doi: 10.1016/j.rehab.2022.101704. Epub 2022 Dec 2.

  PMID: 36115574 RESULT

• Maeneja R, Silva CR, Ferreira IS, Abreu AM. Aerobic physical exercise versus dual-task cognitive walking in cognitive rehabilitation of people with stroke: a randomized clinical trial. Front Psychol. 2023 Oct 13;14:1258262. doi: 10.3389/fpsyg.2023.1258262. eCollection 2023.

  PMID: 37901076 RESULT

• Montero-Almagro G, Bernal-Utrera C, Geribaldi-Doldan N, Nunez-Abades P, Castro C, Rodriguez-Blanco C. Influence of High-Intensity Interval Training on Neuroplasticity Markers in Post-Stroke Patients: Systematic Review. J Clin Med. 2024 Mar 29;13(7):1985. doi: 10.3390/jcm13071985.

  PMID: 38610750 RESULT

• Gjellesvik TI, Becker F, Tjonna AE, Indredavik B, Lundgaard E, Solbakken H, Brurok B, Torhaug T, Lydersen S, Askim T. Effects of High-Intensity Interval Training After Stroke (The HIIT Stroke Study) on Physical and Cognitive Function: A Multicenter Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Sep;102(9):1683-1691. doi: 10.1016/j.apmr.2021.05.008. Epub 2021 Jun 6.

  PMID: 34102144 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aruba Saeed, Phd

CONTACT

+92 334 4399403; aruba.saeed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)