Postural Management of Hyperkyphosis in Cardiac Rehab Patients
- Conditions
- Hyperkyphosis
- Interventions
- Other: Home-based exercise programOther: No intervention
- Registration Number
- NCT06563882
- Lead Sponsor
- Hadassah Medical Organization
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home-based exercise program Home-based exercise program Intervention Group: Hyperkyphotic participants will participate in a home exercise program designed to improve thoracic spine and shoulder mobility and flexibility, while also strengthening spine extensor muscles, alongside a cardiac rehabilitation exercise program. The home-based program will include six exercises to be performed three times a week over a period of 12 weeks. Cardiac rehabilitation exercise program - Hyperkyphosis No intervention Control Group: Hyperkyphotic participants will participate in a 12-week cardiac rehabilitation exercise program, consisting of two one-hour sessions per week at the cardiac rehabilitation center. These sessions will include aerobic activity along with a variety of resistance, flexibility, and balance exercises. cardiac rehabilitation exercise program - without hyperkyphosis No intervention Control Group: Participants without hyperkyphosis will participate in a 12-week cardiac rehabilitation exercise program, consisting of two one-hour sessions per week at the cardiac rehabilitation center. These sessions will include aerobic activity along with a variety of resistance, flexibility, and balance exercises.
- Primary Outcome Measures
Name Time Method Degree of Kyphosis Assessment will occur at baseline, after 6 weeks, and upon completion of the 12-week program. This measure will be obtained using a 60-centimeter flexicurve ruler, placed over the subject's back, from the C7 spinous process down to the T12 spinous process. Once attached to the back, the flexicurve molds according to its shape, allowing tracing of the thoracic curve onto paper. Maximum width and length measurements are then taken of the curve in centimeters in order to calculate the kyphosis index. Kyphosis index is calculated as the ratio of thoracic width to thoracic length. A higher index value indicates a greater degree of kyphosis, with values exceeding 13 considered hyperkyphosis. Assessment will occur at the program's start, after 6 weeks, and upon completion of the 12-week program.
- Secondary Outcome Measures
Name Time Method Maximum Metabolic Equivalents (METs) The measurement will be taken at baseline and upon completion of the 12-week program. This measure represents the total workload achieved during a symptom-limited graded exercise test in order to assess the subject's cardiovascular exercise capacity. The METs score will be calculated using a validated computerized algorithm. The test will be performed on a treadmill, with the workload progressively increasing every 2-3 minutes (depending on the chosen protocol). The test protocol will be determined based on the participant's age, overall physical fitness level, and any orthopedic limitations. During the test, the electrical activity of the heart will be monitored using an electrocardiogram (ECG) for diagnostic purposes, such as the detection of myocardial ischemia (e.g., ST-segment depression). The test will be terminated when the participant reaches or exceeds 85% of the maximum predicted heart rate, when the participant indicates an inability to continue, or if there are any clinical symptoms, abnormal findings in the ECG, or abnormal physiological responses.
Peak Heart Rate The measurement will be taken at baseline and upon completion of the 12-week program. The maximum heart rate attained during a graded exercise test.
Peak Systolic and Diastolic Blood Pressure The measurement will be taken at baseline and upon completion of the 12-week program. The maximum systolic and diastolic blood pressure measured during a graded exercise test.
Time to complete the Five Times Sit to Stand Test (FTSST) The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program. This test is used to assess leg strength, dynamic balance and functional mobility. Subjects are timed in seconds as they rise from and return to a chair (standard height, 43-45 cm) five times. The performance in the test is recorded in seconds. Faster completion times indicate better performance. Testing occurs at the program's start, after 6 weeks, and upon completion of the 12-week program.
Time to climb one flight of stairs The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program. This test evaluates leg strength and functional mobility by timing subjects as they climb an 11-step flight of stairs as quickly as possible. Each step is 16 centimeters in height and 33 centimeters in depth. Testing will occur at the program's start, after 6 weeks, and upon the completion of the 12-week program.
Timed Up & Go Test (TUG) The The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program. The TUG test will be used to assess dynamic balance and functional mobility by timing the subjects as they rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The test score will be recorded in seconds, with a shorter TUG time indicating better results.
Distance covered in a six-minute walk test The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program. The Six-Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and functional mobility by measuring the distance covered by the subject over a flat 25-meter corridor in 6 minutes. Greater distance covered indicates a better result. The score will be obtained in meters.
Forced Vital Capacity (FVC) The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program. This measure will be obtained through spirometry test as part of pulmonary function assessment. It represents the largest amount of air the subject can forcefully exhale after taking the deepest possible breath. Test results will be reported in liters.
Forced Expiratory Volume in one second (FEV1) The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program. This measure will be obtained through a spirometry test as part of pulmonary function assessment. It represents the maximum amount of air that the subject can force out his lungs in 1 second following maximal inhalation. Test results will be reported in liters.
Adherence to home-based program From enrollment to the end of treatment at 12 weeks Adherence to the home-based exercise program will be calculated as a percentage out of the total number of exercises provided during a 12-week program (36 exercises in total).
Functional Reach Test (FRT) The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program. The FRT test will be used to assess dynamic balance by measuring how far a participant can reach while maintaining a fixed base of support. Participants will stand adjacent to a wall and extend the arm that is closer to the wall as far as possible. The distance reached by the participant along a measuring tape affixed to the wall is measured in centimeters. Three trials will be performed, and the average of the last two trials will be calculated.
Trial Locations
- Locations (1)
Hadassah Medical Organization
🇮🇱Jerusalem, Israek, Israel