HyperkyphosisNCT06563882
Postural Management of Hyperkyphosis in Cardiac Rehab Patients
A study testing Home-based exercise program in people with Hyperkyphosis, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperkyphosis
- What is being tested?
- Home-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Apr 2024to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postural Management of Hyperkyphosis to Improve Motor Performance and Pulmonary Function in Cardiac Rehabilitation Patients
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.
- Conditions
- Hyperkyphosis
- Being tested
- Home-based exercise program, No intervention
- Keywords
- Home-based program, Graded exercise test, Spirometry, Flexicurve ruler, Six-minute walk test, Posture, Kyphosis index, Physical functional capacity, TUG test
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise programOther
The program will comprise of six exercises aimed at improving the mobility of the thoracic spine and shoulders, strengthening the extensor muscles of the spine, and enhancing the flexibility of the chest and anterior shoulders. Progression within the program will involve increasing exercise duration or repetitions/sets, along with implementing postural corrections in compound exercises. Participants will be instructed to perform the exercises at least three times a week.
To heighten participants awareness of their daily posture, they will receive a daily scheduled message via WhatsApp reminding them to focus on their posture. Once a week, participants will be asked to submit a home exercise tracking report to monitor their adherence to the program. Additionally, exercises execution will be reviewed every two weeks, and adjustments to the program will be made accordingly.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Home-based exercise program | Experimental | 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. Receives: Other: Home-based exercise program |
| Cardiac rehabilitation exercise program - Hyperkyphosis | Other | 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. Receives: Other: No intervention |
| cardiac rehabilitation exercise program - without hyperkyphosis | Other | 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessment will occur at baseline, after 6 weeks, and upon completion of the 12-week program.
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start21 Apr 2024
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Zinman College of Physical Education and Sports Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563882
- Sponsor's protocol ID
- 0172-23HMO
- Status last verified
- Sep 2025
- First submitted
- 4 May 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Management of Hyperkyphosis to Improve Motor Performance and Pulmonary Function in Cardiac Rehabilitation Patients
- ClinicalTrials.gov ID
- NCT06563882
- Acronym / sponsor ID
- 0172-23HMO
- Conditions
- Hyperkyphosis
- Keywords
- Home-based program, Graded exercise test, Spirometry, Flexicurve ruler, Six-minute walk test, Posture, Kyphosis index, Physical functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Zinman College of Physical Education and Sports Sciences
- Study start
- 21 Apr 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home-based exercise program | Experimental | Other: Home-based exercise programIntervention 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 | Other | Other: No interventionControl 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 | Other | Other: No interventionControl 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exercise programThe program will comprise of six exercises aimed at improving the mobility of the thoracic spine and shoulders, strengthening the extensor muscles of the spine, and enhancing the flexibility of the chest and anterior shoulders. Progression within the program will involve increasing exercise duration or repetitions/sets, along with implementing postural corrections in compound exercises. Participants will be instructed to perform the exercises at least three times a week. To heighten participants awareness of their daily posture, they will receive a daily scheduled message via WhatsApp reminding them to focus on their posture. Once a week, participants will be asked to submit a home exercise tracking report to monitor their adherence to the program. Additionally, exercises execution will be reviewed every two weeks, and adjustments to the program will be made accordingly. | Other | Home-based exercise program |
| No interventionNo intervention | Other | Cardiac rehabilitation exercise program - Hyperkyphosis, cardiac rehabilitation exercise program - without hyperkyphosis |
Primary outcome
Degree of Kyphosis
Time frame: 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.
11 secondary outcomes
Maximum Metabolic Equivalents (METs)
Time frame: The measurement will be taken at baseline and upon completion of the 12-week program.
Peak Heart Rate
Time frame: The measurement will be taken at baseline and upon completion of the 12-week program.
Peak Systolic and Diastolic Blood Pressure
Time frame: The measurement will be taken at baseline and upon completion of the 12-week program.
Distance covered in a six-minute walk test
Time frame: 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)
Time frame: 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
Time frame: The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
Functional Reach Test (FRT)
Time frame: The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
Timed Up & Go Test (TUG)
Time frame: The The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
Forced Vital Capacity (FVC)
Time frame: 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)
Time frame: The test will be conducted at baseline, after 6 weeks, and upon completion of the 12-week program.
Adherence to home-based program
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise program in people with Hyperkyphosis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Kyphosis (time frame: Assessment will occur at baseline, after 6 weeks, and upon completion of the 12-week program.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.