Postural Management of Hyperkyphosis in Cardiac Rehab Patients
NCT Number: NCT06563882
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hyperkyphosis
Interventions: OTHER: Home-based exercise program|OTHER: No intervention
Sponsor: Hadassah Medical Organization
Collaborators: Zinman College of Physical Education and Sports Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-21
Completion Date: 2025-05
Locations: Hadassah Medical Organization, Jerusalem, Israek, 91120, Israel

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.

Primary Outcome Measures: Degree of Kyphosis, 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., Assessment will occur at baseline, after 6 weeks, and upon completion of the 12-week program.
Secondary Outcome Measures: Maximum Metabolic Equivalents (METs), 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., The measurement will be taken at baseline and upon completion of the 12-week program.|Peak Heart Rate, The maximum heart rate attained during a graded exercise test., The measurement will be taken at baseline and upon completion of the 12-week program.|Peak Systolic and Diastolic Blood Pressure, The maximum systolic and diastolic blood pressure measured during a graded exercise test., The measurement will be taken at baseline and upon completion of the 12-week program.|Distance covered in a six-minute walk test, 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., The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.|Time to complete the Five Times Sit to Stand Test (FTSST), 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., The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.|Time to climb one flight of stairs, 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., The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.|Functional Reach Test (FRT), 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., The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.|Timed Up & Go Test (TUG), 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., The The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.|Forced Vital Capacity (FVC), 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., The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.|Forced Expiratory Volume in one second (FEV1), 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., The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.|Adherence to home-based program, 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)., From enrollment to the end of treatment at 12 weeks