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StrokeNCT07274748

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

A study testing Group A: High-Intensity Interval Training (HIIT) and Group B: Intermittent Functional Training (IFT) in people with Stroke, run by Riphah International University at 2 sites in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Stroke
What is being tested?
Group A: High-Intensity Interval Training (HIIT) and Group B: Intermittent Functional Training (IFT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
2 sitesPakistan
Study dates
5 Nov 2025to 30 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aruba Saeed, Phd contact

+92 334 4399403

aruba.saeed@gmail.com

Pakistan2 sites, 2 recruiting
  • Riphah International University

    Daska Kalan, Punjab Province, 51010

    Shamama Naqvi, MS. NMPT, 0318 0776872, shamamanaqvi2@gmail.com

    Aruba saeed, Phd, +92 334 4399403, aruba.saeed@gmail.com

    Not yet recruiting
  • Riphah International University

    Daska Kalan, Punjab Province, 51010

    Shamama Naqvi, MS. NMPT, 0318 0776872, shamamanaqvi2@gmail.com

    Aruba Saeed, Phd, +92 334 4399403, aruba.saeed@gmail.com

    Recruiting

Other trials in Pakistan

About this study

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

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.

Read the detailed description

This randomized clinical trial will be conducted at General Hospital Lahore over the duration of ten months enrolling six months post stroke survivors. The 52 patients will be recruited through non-probability convenience sampling technique and will be randomly assigned to either the HIIT or IFT group through online randomizer tool. Both groups will undergo a 12-week intervention, consisting of three sessions per week with alternate-day training. The HIIT group will perform three sessions per week 30 minutes in total with each session consisting of 5 min intervals at 85-95% of their maximum heart rate, with 3-minute active recovery periods, while IFT group will perform three sessions per week 30 minutes in total with each session consisting of 6-9 circuits of task-oriented exercises both including a 5-min warm-up and cool down period. Data will be collected through different assessment tools including NIHSS (The National Institutes of Health Stroke Scale) to assess the severity of stroke, 6-minute walk test (6MWT) for cardiovascular fitness, MoCA (Montreal Cognitive Assessment or The MoCA Test) for cognition and Berg-balance scale (BBS) and TUG (Time Up and Go Test) for mobility and physical function

Conditions
Stroke
Being tested
Group A: High-Intensity Interval Training (HIIT), Group B: Intermittent Functional Training (IFT)
Keywords
Cardiorespiratory fitnss ,Cognition , Stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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

Study groups in NCT07274748
Study groupRoleWhat they receive
Group A: High-Intensity Interval Training (HIIT)ExperimentalThe 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:
Receives: Other: Group A: High-Intensity Interval Training (HIIT)
Group B: Intermittent Functional Training (IFT)ExperimentalIFT 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
Receives: Other: Group B: Intermittent Functional Training (IFT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

  2. 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)

    Measured: 12 week

  3. 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

    Measured: 12 week

  4. 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

    Measured: 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study start5 Nov 2025
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07274748
Sponsor's protocol ID
REC/0271 Shamama Naqvi
Status last verified
Nov 2025
First submitted
28 Nov 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18569856
  • 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.

    PubMed 36115574
  • 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.

    PubMed 37901076
  • 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.

    PubMed 38610750
  • 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.

    PubMed 34102144

Questions about this trial

What is this clinical trial studying?

A study testing Group A: High-Intensity Interval Training (HIIT) and Group B: Intermittent Functional Training (IFT) in people with Stroke, run by Riphah International University at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aruba Saeed, Phd (+92 334 4399403, aruba.saeed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

National Institutes of Health Stroke Scale(NIHSS) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07274748, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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