ClinicalTrials.gg
RecruitingNCT06539520Updated Mar 21, 2025

Aerobic Training on Cardio-respiratory Fitness and Health Related Quality of Life

An interventional study of Aerobic training program and Selected physical therapy program for post stroke patients in Hemiplegia, Spastic, sponsored by Adly A Adam. Recruiting at 1 site in Egypt. Open to participants aged 55 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Adly A Adam · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
55 Years to 65 Years
Sex
All
01

Study summary

Stroke is a major health problem among Egyptian population; an obvious raise in stroke prevalence in all Egyptian governorates. Most stroke survivors commonly develop disabilities those were correlated with restricted physical activity levels. Stroke survivors' cardio-respiratory fitness has several negative impacts such as elevated risk of being affected by other cardiovascular diseases. So, the current study will be conducted to cover the lack in literature concerning the effect of aerobic training on cardiovascular endurance in stroke survivors aiming to faster recovery and reduce the risk of cardiac dysfunction and recurrent strokes.

Read the detailed description

Stroke as a cerebrovascular accident has a significant prevalence, as well it was addressed a one of major etiologies for other comorbidities, even mortality. Where, cardiac rehabilitation is a structured exercise program that almost designed to offer an opportunity to break the inactivity cycle, reduce associated cardiovascular risks, also improve perceived confidence and quality of life in stroke survivors . Therefore, aerobic training could be defined as a core component that focuses on cardio-respiratory fitness, walking speed and endurance for stroke survivors. Up on that, this clinical trial will be conducted to investigate the effect of aerobic training on cardiorespiratory fitness and health related quality of life in stroke survivors. It will be conducted on eighty post stroke patient (hemiplegic; 55-65 years old with functional ambulatory category more than 3) from Outpatient clinic of neurological department of El-Kasr El-Aini Hospital. They will be allocated into 2 groups; Group A will involves 40 patients will receive aerobic training program, plus traditional physical therapy program. While, Group B will involves 40 patients will receive traditional physical therapy program only. 6-Menutes walk test, Stroke impact scale are the outcome measures.

02

Conditions studied

  • Hemiplegia, Spastic

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03

In context

Hemiplegia

446 studies on the registry are indexed under Hemiplegia; 90 are open to participants now.

This study's planned enrollment of 80 is above the median of 34 across 370 interventional studies indexed under Hemiplegia.

Browse Hemiplegia studies →

Lead sponsor

Adly A Adam is the lead sponsor of 12 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Both genders,
  • Age range is 55-65 years old,
  • Within one year post ischemic stroke,
  • Right or left sided stroke,
  • hemiplegic and hemiparetic patients,
  • Medications include anti-spastics, Beta blockers, ACE inhibitors, and diuretics.
  • Functional ambulatory category of three or more,
  • Hemodynamic stable,
  • Did not participate in any other research study within at least 3 months.

Exclusion criteria

Exclusion Criteria:

  • Sever anemia,
  • Uncontrolled hypertension, or diabetes mellitus,
  • Recent cardiothoracic surgeries,
  • Cognitive disorders ' less than 24'
  • Auditory and visual problems,
  • Dementia,
  • Modified Rankin score 3 or more,
  • Seizure,
  • Musculoskeletal disorders,
  • Stroke or serious head trauma within last 3 months,
  • Vertrobrobasilar stroke,
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Aerobic Training Group A

    Forty post-stroke patients will receive aerobic training program, plus selected physical therapy program.

    Other: Aerobic training program · Other: Selected physical therapy program for post stroke patients

  • Other
    Control Group B

    Forty post-stroke patients will receive selected physical therapy program.

    Other: Selected physical therapy program for post stroke patients

Interventions

  • OtherAerobic training program

    Aerobic training program; on interval moderate mode, 3 session per week, for 16 weeks, along 30-40 minutes, plus 5-10 minutes of warm up and 5 minutes cooling down, with 50-80% of maximal heart rate for each patient based on age. that progress every month by 10% directed by rating of perceived exertion.

  • OtherSelected physical therapy program for post stroke patients

    Selected neurorehabilitation for 1 hour session; 3 sessions per week, for 16 weeks. It involves weight shift side to side, reaching toward weak side, shoulder flexion overhead, shoulder external rotation, overhead press, shoulder internal rotation with Thera-band, heel slides, bridging, lying terminal knee extension, toe and heel raises, sensory reeducation exercises, and body awareness therapy.

06

What researchers measure

Primary outcomes

  1. 6-Minutes walk test

    A sub-maximal exercise test will be used to assess aerobic capacity and endurance, and functional capability of stroke survivors. 6-Minutes walk test requires stop watch, measuring/ trundle wheel, 30 meter stretch of unimpeded walk way, 2 cones, pulse oximeter, and Borg breathlessness scale. It has excellent reliability, validity, and responsiveness. Its' gained scoring values will be expressed in meters that if more indicates better recovery.

    Time frame: Baseline of the study, and after 16 weeks at the end of the study.

Secondary outcomes

  1. Stroke Impact Scale

    A stroke-specific, self-reported, health status measure. It is designed to assess multi-dimensional stroke outcomes involving strength (4 items), hand function (5 items), activities of daily living/ instrumental activities of daily living (10 items), mobility (9 items), communication (7 items), emotion (9 items), memory (7 items), and participation (8 items). The over score ranged from Zero indicating no recovery up to 100 indicating full recovery

    Time frame: Baseline of the study, and after 16 weeks at the end of the study.

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Aug 2025, 15 months after the start.

Of 223 non-industry interventional studies with no phase under Hemiplegia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 15 months is above that.

Counting every sponsor, half of 228 studies reached it within 12 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2024
First posted
Aug 6, 2024
StartActual
May 1, 2024
Primary completionEst.
Aug 2025
CompletionEst.
Oct 2025
Last update
Mar 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06539520
Lead sponsor
Adly A Adam
Responsible party
Adly A Adam (Lecturer Physical Therapy, Cairo University) — Sponsor-investigator
First posted
Aug 6, 2024
Start date
May 1, 2024
Primary completion
Aug 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Mar 21, 2025

Study contacts

Marihan A Mohamed, B.Sc
Contact
info@pt.cu.edu.eg
+2035676103 ext. 105
Shimaa M Ali, PHD
Contact
info@pt.cu.edu.eg
+2035676103 ext. 103
Ali F Rahmy, PHD
study director · Professor of Cardiovascular, Respiratory Disorders

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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