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

NCT ID: NCT07274748

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-05
• Study Completion Date: 2026-05-30

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.

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

Study Design

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

Study Groups

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:

Group Type: EXPERIMENTAL

Group A: High-Intensity Interval Training (HIIT)

Intervention Type: 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)

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

Group Type: EXPERIMENTAL

Group B: Intermittent Functional Training (IFT)

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Riphah International University

Daska Kalan, Punjab Province, Pakistan

Site Status: NOT_YET_RECRUITING

Riphah International University

Daska Kalan, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Aruba Saeed, Phd

Role: CONTACT

aruba.saeed@gmail.com

+92 334 4399403

Facility Contacts

Shamama Naqvi, MS. NMPT

Role: primary

shamamanaqvi2@gmail.com

0318 0776872

Aruba saeed, Phd

Role: backup

aruba.saeed@gmail.com

+92 334 4399403

Shamama Naqvi, MS. NMPT

Role: primary

shamamanaqvi2@gmail.com

0318 0776872

Aruba Saeed, Phd

Role: backup

aruba.saeed@gmail.com

+92 334 4399403

References

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.

Reference Type: RESULT

PMID: 18569856 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36115574 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37901076 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38610750 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34102144 (View on PubMed)

Other Identifiers

REC/0271 Shamama Naqvi

Identifier Type: -

Identifier Source: org_study_id