Clinical trial NCT06563882: Postural Management of Hyperkyphosis in Cardiac Rehab Patients
Official title: Postural Management of Hyperkyphosis to Improve Motor Performance and Pulmonary Function in Cardiac Rehabilitation Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperkyphosis
Keywords: Home-based program
Graded exercise test
Spirometry
Flexicurve ruler
Six-minute walk test
Posture
Kyphosis index
Physical functional capacity
TUG test
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Zinman College of Physical Education and Sports Sciences
First posted: 2024-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the efficacy of a home-based exercise program in managing hyperkyphosis, and its impact on physical performance and pulmonary function among cardiac rehabilitation patients.

The primary research question is: Can a home-based kyphosis-specific exercise program reduce thoracic hyperkyphosis and improve physical ability in cardiac patients undergoing cardiac rehabilitation? The study will consist of three groups: 1) Hyperkyphotic participants undergoing a 12-week exercise program at home, alongside a cardiac rehabilitation exercise program, 2) Hyperkyphotic participants solely undergoing cardiac rehabilitation exercise program, and 3) Participants without hyperkyphosis solely undergoing cardiac rehabilitation exercise program.

The groups will be evaluated based on measurements of kyphosis index, physical performance and spirometry at the beginning, after 6 weeks, and upon completion of the 12-week program.


Eligibility criteria: Inclusion Criteria:

* Heart patients who will be admitted for cardiac rehabilitation at Hadassah - Mount Scopus Hospital
* Normal stress test results.
* Independent mobility.
* Stable hemodynamic and respiratory status.
* Ability to speak and read basic Hebrewץ
* Ability to watch videos on a mobile phone or computer.
* Not receiving any other forms of physical therapy or physical treatment.

Exclusion Criteria:

* Presence of unstable angina.
* Neurological disorders or mental illnesses that interfere with communication.
* Movement disorders due to neurological disease.
* Severe orthopedic limitations hindering the execution of motor exercises.

Primary outcomes:
measure: Degree of Kyphosis
timeFrame: Assessment will occur at baseline, after 6 weeks, and upon completion of the 12-week program.
Secondary outcomes:
measure: Maximum Metabolic Equivalents (METs)
timeFrame: The measurement will be taken at baseline and upon completion of the 12-week program.
measure: Peak Heart Rate
timeFrame: The measurement will be taken at baseline and upon completion of the 12-week program.
measure: Peak Systolic and Diastolic Blood Pressure
timeFrame: The measurement will be taken at baseline and upon completion of the 12-week program.
measure: Distance covered in a six-minute walk test
timeFrame: The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
measure: Time to complete the Five Times Sit to Stand Test (FTSST)
timeFrame: The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
measure: Time to climb one flight of stairs
timeFrame: The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
measure: Functional Reach Test (FRT)
timeFrame: The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
measure: Timed Up & Go Test (TUG)
timeFrame: The The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
measure: Forced Vital Capacity (FVC)
timeFrame: The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
measure: Forced Expiratory Volume in one second (FEV1)
timeFrame: The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
measure: Adherence to home-based program
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
state: Israek
Study officials:
References: