- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06278259
Telerehabilitation Program Bases Aerobic and Baduanjin Exercises in Post Stroke Elderly Patients
Telerehabilitation Program Bases Aerobic and Baduanjin Exercises on Cognition , Sleep Quality and Physical Performance in Post Stroke Elderly Patients
Study Overview
Status
Conditions
Detailed Description
It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and will divided into two groups. The study group participants will involve in Telerehabilitation sessions will be based on low-impact rhythmic movements, guided by video, according to the protocol of (Schachter et al., 2003). The telerehabilitation program will be moderately intense aerobic exercise 3 times per week and will be included 3 parts: warm-up, central part, and cool-down. Each session : 30 min, 3 sessions/ week for 3 months.
The repetition rate will determine the intensity of the exercises: 10, 15, 20, or 25 repetitions per minute. The exercise intensity of each telerehabilitation session will be individually adjusted by the participants' Modified Borg perceived exertion. With the Baduanjin exercise program is delivered individually, at each patient's home, through telerehabilitation, with direct remote supervision by a physiotherapist. Each session consists of a short preparatory phase (stretching exercises and abdominal breathing patterns) follows by a set of seven movements, adapts from the eight-section brocade Baduanjin exercise that originally comprises eight movements, repeated a certain number of times.The control group will receive the same aerobic exercises only
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: marwa elsayed, PhD
- Phone Number: 0201156033818
- Email: marwa.elsaid@cu.edu.eg
Study Locations
-
-
Dokki
-
Cairo, Dokki, Egypt, 11432
- Recruiting
- Faculty of Physical Therapy
-
Contact:
- marwa M elsayed, phd
- Phone Number: 02 01156033818
- Email: marwadd999@gmail.com
-
Contact:
- marwa M elsayed, ph.d
- Phone Number: 02 01156033818
- Email: marwadd999@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 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.
Exclusion Criteria:
• 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
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
|
It is an interventional study in which 60 stroke patients estimated to enrol according to random allocation and divided into two groups.
The study group participants involve in Telerehabilitation sessions is based on low-impact rhythmic movements, guided by video, according to the protocol of (Schachter et al., 2003).
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
|
Active Comparator: control group
The control group will receive the same aerobic exercises only
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physical function
Time Frame: 12 weeks
|
physical performance battery
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: 12 weeks
|
mini mental state examination
|
12 weeks
|
sleep quality
Time Frame: 12 weeks
|
The Pittsburgh Sleep Quality Index
|
12 weeks
|
participants' satisfaction with the program
Time Frame: 12 weeks
|
Telemedicine Satisfaction Questionnaire
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: marwa elsayed, PhD, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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