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

November 28, 2025 updated by: Riphah International University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Daska Kalan, Punjab Province, Pakistan, 51010
        • Not yet recruiting
        • Riphah International University
        • Contact:
        • Contact:
      • Daska Kalan, Punjab Province, Pakistan, 51010
        • Recruiting
        • Riphah International University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:• Age 50-75 years

  • 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.

Exclusion Criteria:• Significant resting ECG abnormalities

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: High-Intensity Interval Training (HIIT)

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)
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.
Experimental: Group B: Intermittent Functional Training (IFT)

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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale(NIHSS)
Time Frame: 12 weeks
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 )
Time Frame: 12 week
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
Time Frame: 12 week
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
Time Frame: 12 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/0271 Shamama Naqvi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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