NCT07148453

Brief Summary

This randomized controlled trial will determine the effects of combining mobile application-based cognitive training with aerobic exercise on cognitive function and the effects of combining mobile application-based cognitive training with aerobic exercise on quality of life in post-stroke patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

August 24, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

Stroke rehabilitationcognitive impairmentLumositybrain training games

Outcome Measures

Primary Outcomes (4)

  • Montreal Cognitive Assessment

    Brief cognitive function assessment tool consisting of 12 items. Visuospatial, executive functioning, short-term memory, attention/concentration/Working memory, Language and orientation. Normal Cognition= 26-30 Cognitive impairment: Mild=18-25, Moderate=10-17, Severe= under 10

    6 weeks

  • Trail Making Test A and B

    Measure the cognitive function executive. In part A the patient draws lines to join numbered circles (1-25) to connect them in ascending order. In part B, the patient connects the circles alternating between numbers (1-13) and letters (A-L). Trail A; Average; 29 Sec Deficient; \>78 sec Rule of Thumb Most in 90 sec Trail B; Average; 75 sec Deficient; \>273 sec. Rule of Thumb Most in 3min

    6 weeks

  • 6-Minute Walk Test (6MWT)

    Submaximal exercise test that assesses aerobic capacity and endurance by measuring the distance an individual can walk on a flat, hard surface in a period of 6 minutes. It reflects functional exercise performance and cardiovascular fitness. Commonly used in stroke rehabilitation to evaluate improvements in mobility and endurance.

    6 weeks

  • Stroke Specific Quality of Life scale (SS-QOL)

    The self-reported questionnaire consists of 49 items across 12 domains. Mobility, Mood, Self-care, Cognition, Social roles, Upper extremity function, work, sleep, family roles, personality, Vision, and strength. Scoring based on a Likert scale ranging from 1-5.

    6 weeks

Study Arms (2)

Lumosity-based cognitive training + aerobic exercise

EXPERIMENTAL

The experimental group will receive training through a smartphone-based brain training program using the Lumosity app, as well as aerobic exercise on a bicycle ergometer for 18 sessions other days for 6 weeks, 3 times per week, every session for 40 minutes (20 minutes aerobic training on a stationary bicycle ergometer followed by 20 minutes for Lumosity training application on the smartphone).

Other: Experimental Group

Aerobics + Traditional mental exercises

ACTIVE COMPARATOR

The control group will participate in aerobic training on a bicycle ergometer as well as mental exercises for 18 sessions every other day for 6 weeks, 3 sessions/week, each for 40 minutes.

Other: Control Group

Interventions

The experimental group will receive training through a smartphone-based brain training program using the Lumosity app, as well as aerobic exercise on a bicycle ergometer for 18 sessions other days for 6 weeks, 3 times per week, every session for 40 minutes (20 minutes aerobic training on a stationary bicycle ergometer followed by 20 minutes for Lumosity training application on the smartphone).

Lumosity-based cognitive training + aerobic exercise

The control group will participate in aerobic training on a bicycle ergometer as well as mental exercises for 18 sessions every other day for 6 weeks, 3 sessions/week, each for 40 minutes

Aerobics + Traditional mental exercises

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both males and females
  • Patients aged 30-75 years
  • Spasticity grade (1 to 1+) based on the modified Ashworth scale (MAS)
  • Patients with CVA Education level: matriculation
  • at least Single-event stroke patients,
  • with a post-stroke duration of 3 to 18 months.
  • Mild to moderate cognitive impairment with a score between 10-25 on MOCA

You may not qualify if:

  • Patients with a history of recurrent stroke or hemiparesis caused by conditions other than stroke.
  • Patients with severe cardiovascular issues (e.g., unstable angina, severe coronary artery disease, or untreated congestive heart failure).
  • Patients with dementia, depression, visual or auditory impairments, and other neurological conditions (e.g., Multiple Sclerosis, Parkinson's disease) affecting cognition.
  • Individuals on medications known to affect cognitive function.
  • Patients with low educational levels (illiterate).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Islamabad, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

StrokeCognitive Dysfunction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Umber un Nisa, MS-NMPT*

    Riphah International Unversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2025

First Posted

August 29, 2025

Study Start

August 20, 2025

Primary Completion

February 20, 2026

Study Completion

February 20, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations