NCT06278259

Brief Summary

It is an interventional study in which 68 stroke patients are estimated to be enrolled according to random allocation and will be divided into two groups. The study group participants will be involved in Telerehabilitation sessions, which will be based on aerobic exercises, guided by video with the Baduanjin exercise program; the control group will receive the same aerobic exercises only

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

February 14, 2024

Last Update Submit

August 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • six-minute walk test

    The 6MWT is a reliable and good measure of functional capacity. The test will be carried out according to the guidelines set forth by the American Thoracic Society (ATS).

    12 weeks

Secondary Outcomes (5)

  • Cognitive function

    12 weeks

  • sleep quality

    12 weeks

  • functional independence measure

    12 weeks

  • physical function

    12 weeks

  • berg balance scale

    12 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

The telerehabilitation program is moderately intense aerobic exercise 3 times per week and included 3 parts: warm-up, central part, and cool-down. Each session : 30 min, 3 sessions/ week for 3 months.With the Baduanjin exercise program is delivered individually, at each patient's home, through telerehabilitation, with direct remote supervision by a physiotherapist

Other: Telerehabilitation program bases aerobic and Baduanjin exercises

control group

ACTIVE COMPARATOR

The control group will receive the same aerobic exercises only

Other: Telerehabilitation program bases aerobic exercises

Interventions

It is an interventional study in which 68 stroke patients are estimated to enroll according to random allocation and divided into two groups. The study group participants involve in Telerehabilitation sessions is based on aerobic exercises, guided by video. The telerehabilitation program is aerobic exercise 3 times per week for 3 months. With the Baduanjin exercise program is delivered individually, at each patient's home, through telerehabilitation, with direct remote supervision by a physiotherapist

experimental group

The telerehabilitation program is aerobic exercise 3 times per week for 3 months.

control group

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • The subject selection will be according to the following criteria:
  • All Patients of this study will be diagnosed as stroke and the diagnosis will be confirmed by computed tomography or MRI (El-Tamawy et al., 2021).
  • Age of patients will be more than or equal 65years (males and females).
  • All patients will be hemodynamically stable.

You may not qualify if:

  • The potential participants will be excluded if they meet one of the following criteria:
  • Patients who cannot follow instructions as sensory aphasia, blindness, dementia, and deafness.
  • Patients with any orthopedic, neurological, or chest disorders that affect trunk muscles control or cause respiratory disorders as COPD.
  • Patients with psychiatric disorders.
  • Patients with unstable cardiovascular conditions.
  • uncontrolled hypertension, or other concomitant respiratory diseases
  • participate at any research or rehabilitation program during the period of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, Dokki, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • marwa elsayed, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

marwa elsayed, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 26, 2024

Study Start

February 20, 2024

Primary Completion

November 28, 2025

Study Completion

December 30, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

sharing

Shared Documents
STUDY PROTOCOL
Time Frame
one year
Access Criteria
after acceptance of the publishing journal
More information

Locations