Cardiac RehabilitationNCT05967780
Comparison of Open Heart Surgery Patients With Forward Head Posture With and Without Perioperative Therapeutic Exercise
A study testing Group A: Patients with FHP receiving standard cardiac rehabilitation, Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises and Group C: Patients without FHP receiving standard cardiac rehabilitation in people with Cardiac Rehabilitation, run by Health Education Research Foundation (HERF) at 1 site in Pakistan.
Trial summary
Comparison of open heart surgery patients with forward head posture with and without perioperative therapeutic exercise on craniovertebral angle, pulmonary function, balance and quality of life Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Group A: Patients with FHP receiving standard cardiac rehabilitation, Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises and Group C: Patients without FHP receiving standard cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Aug 2023to 31 Dec 2023
- 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 30 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Craniovertebral angle < 50 degrees (included in Group A \& B), Craniovertebral angle ≥ 50 degree (included in Group C)
- First elective coronary artery bypass graft surgery, valve replacement, or both through a median sternotomy
- Extubated within 6 hours after surgery
Who cannot join
- Subjects with a history of surgery or any diagnosed pathology or clinical deformity or any musculoskeletal injury within the last six months to the spine or thorax or shoulder or lower extremity
- Any comorbid lung disease
- Patients having angina pectoris while doing therapeutic exercises
- Neurological dis¬orders, neuromuscular disorders, psychiatric, dizziness and blurred vision
- Inability to stand or walk independently
- Leg length discrepancy
Show all 11Show fewer
- Have been reoperated on/ History of previous cardiac surgery
- Postoperative cardiac dysfunction, hemodynamically unstable, ventilator dependent
- Emergency cardiac surgery
- A length of stay in the intensive care unit for 5 days or more due to medical reasons after cardiac surgery
- Postoperative wound infections or sternal instability as diagnosed by medical staff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Open Heart Surgery Patients With Forward Head Posture With and Without Perioperative Therapeutic Exercise on Craniovertebral Angle, Pulmonary Function, Balance and Quality of Life
Comparison of open heart surgery patients with forward head posture with and without perioperative therapeutic exercise on craniovertebral angle, pulmonary function, balance and quality of life
Read the detailed description
Open heart surgery is at high risk of postoperative complications including pulmonary disorders, balance dysfunction and affects quality of life. These complications contribute to morbidity and mortality and increase hospitalization stay and its associated costs. The high prevalence of forward head posture (FHP) in the community is also associated with stated complications like pulmonary disorders, balance dysfunction and affecting quality of life. This close association of these complications in a person with forward head posture undergoing open heart surgery may further heighten the risks. The aim of this study is to evaluate the effects of therapeutic exercises on craniovertebral angle, pulmonary disorders, static and dynamic balance and quality of life in open heart surgery patient having forward head posture. This study will be a prospective, parallel-group, allocation concealment, randomized control, patient and assessor blind trial. Patients (n=53) who undergo open heart surgery via median sternotomy with forward head posture will be recruited from a cardiac hospital. Participants will be divided into three groups. Participants with FHP will be randomized into two groups; 1) patients with FHP will receive standard cardiac rehab protocol, 2) patients with FHP will receive standard cardiac rehab protocol with therapeutic exercise for forward head posture, and 3) participants without FHP will receive standard cardiac rehabilitation. The intervention group will receive a combination of stretching and strengthening exercises (including sternocleidomastoid stretch, pectoralis stretch, the supine chin tuck, and scapular retraction) for forward head posture with standard cardiac rehabilitation. The outcome measures will be craniovertebral angle, pulmonary parameters, neck disability index, functional difficulties questionnaire, single-leg stance test, forward reach test, health-related quality of life (SF-36), and Tampa scale for kinesiophobia. Repeated measures analysis of variance will be taken to test the hypothesis and to evaluate the change from baseline (4 weeks before surgery) to one day before surgery, after surgery before discharge and 4 weeks after discharge from the hospital in the intervention group compared with the standard-care group.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Group A: Patients with FHP receiving standard cardiac rehabilitation, Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises, Group C: Patients without FHP receiving standard cardiac rehabilitation
- Keywords
- Balance, Craniovertebral angle, Forward head posture, Open heart surgery, Pulmonary function, Quality of life, Strengthening, Stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Patients with FHP receiving standard cardiac rehabilitationOther
Consenting participants in this group will receive a standard cardiac rehabilitation protocol that includes preoperative education and post-operative exercises, chest physiotherapy, functional mobility and care. Phase 1 begins after the patient has been considered clinically compensated due to the optimization of the clinical treatment and/or the use of an interventional procedure. In this phase, a combination of low-intensity physical exercise (that includes range of motion exercises for upper \& lower extremities + progressive mobilization from sitting on bedside to walking short distance and up to stair climbing), incentive spirometry exercise, percussions, breathing exercises and effective coughing exercises.
Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercisesOther
The participants who give consent will receive standard cardiac rehabilitation protocol (as Group A) with therapeutic exercise in the intervention group.
Therapeutic exercises will be delivered to the participant by treating physiotherapist in physical, verbal and written formats as individualized sessions on the ward 4 weeks before the surgery and keep him doing exercises under supervision while staying in the ward before surgery. A log will be provided to measure performance to ensure program compliance. After discharge from the hospital, the patient will continue exercises at home as performed and guided physically by the therapist and also in the exercises manual and flyer given to the patient. Patients will be instructed to follow therapeutic exercise for 4 weeks pre-operatively and 4 weeks postoperatively after discharge from the hospital.
Group C: Patients without FHP receiving standard cardiac rehabilitationOther
The participants without forward head posture will be included in this group and will receive same standard cardiac rehabilitation as the participants in group A.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Patients with FHP receiving standard cardiac rehabilitation | Active comparator | Consenting participants in this group will receive a standard cardiac rehabilitation protocol. Receives: Other: Group A: Patients with FHP receiving standard cardiac rehabilitation |
| Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises | Experimental | The participants who give consent will receive standard cardiac rehabilitation protocol (as Group A) with therapeutic exercise in the intervention group. Receives: Other: Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises |
| Group C: Patients without FHP receiving standard cardiac rehabilitation | Active comparator | The participants without forward head posture will be included in this group and will receive same standard cardiac rehabilitation as the participants in group A. Receives: Other: Group C: Patients without FHP receiving standard cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craniovertebral angle
For measuring the angle, the reflective markers will be placed on the tragus of the ear and spinous process of the C7. The participant will be asked to stand and maintain her usual upright posture with her arms resting at the sides, and looking straight ahead. The photos will be captured by a digital camera. The camera will be positioned on a tripod 50 cm away from the participant. The axis of the lens of the camera will be placed orthogonal to the sagittal plane of the participant at the level of the shoulder. The photos will be taken repeatedly so that the participant was not exactly aware of the actual time of photography. The craniovertebral angle will be calculated by image. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Forced Vital Capacity (FVC)
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Forced Expired Volume in one second (FEV1)
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Forced Expired Volume in one second/Forced Vital Capacity (FEV1/FVC) ratio
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Peak expiratory flow (PEF)
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
25% of the Force Expiratory Flow (FEF25)
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
75% of the Force Expiratory Flow (FEF75)
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Average flow between 25% and 75% of the Force Expiratory Flow (FEF25-75)
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Standing balance
The Single Leg Stance Test (SLST) is used to assess static balance performance which requires the participant to stand barefoot on their right or left leg (donor's leg) and hold the contralateral leg in approximately 45 degrees of hip flexion and 90 degrees of knee flexion. They are instructed to cross their arms over the chest. The assessor uses a digital chronometer to measure the amount of time patients are able to stand on a single limb. The test ends when the patient's legs touch each other, the non-stance leg touches the floor, or the arms move from the starting position. This process is repeated three times with eyes open and three times with eyes closed. A two-minute rest period between attempts is considered to prevent fatigue. The average of the three trials is calculated separately. The participants will be assessed at baseline, one day before surgery (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Dynamic balance
The Functional Reach Test (FRT) is widely used as a dynamic measure of balance and is a reliable measure of balance for clinical assessment of instability. Participants are asked to stand with their dominant side adjacent to a wall and raise their arm to shoulder height. They are then asked to reach out as far forward as possible while maintaining a firm base of support. A tape measure is attached horizontally to the wall, and the maximum reach distance is recorded as the farthest point of the third metacarpophalangeal joint from the initial (standing) position. In other words, the measures the maximum distance the participants can reach forward from a standing static position. Three trials are performed and the mean value is recorded. The participants will be assessed at baseline, one day before surgery (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Disability
Howard Vernon developed the Neck Disability Index (NDI) in 1989. The Neck Disability Index is now a standard tool to measure self-reported disability due to neck pain. This tool has 10 items and each score from 0 to 5. 50 is the maximum score. To get a percentage score, the score obtained is multiplied by two. The average of all other items is then added to the completed items, if a respondent will not answer one or other question,. NDI is a commonly used tool to measure disability in individuals with forward head posture. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Functional status
The Functional Difficulties Questionnaire measures the functional status of patients following cardiac surgery, with special emphasis on upper extremity and trunk function in patients following median sternotomy. The questionnaire asks patients to rate the difficulty they would experience performing a series of 13 functional upper extremity and trunk tasks. Specifically, patients are required to place a mark along a 10-cm line, with anchors to the left and right of the line, respectively indicating 'no difficulty' and 'maximum difficulty'. For the activities that participants cannot complete when completing the questionnaire, they are required to recall they performed the tasks last time. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Health related Quality of life
Health related quality of life is assessed by SF-36, a common measure used to assess eight domains including physical functioning, role physical functioning, role emotional functioning, mental health, vitality, social functioning, bodily pain and general health. All scale or single-item measurements range in score from 0 to 100 and are managed by interview. The raw subscale scores are converted to 'norm-based' scores using published algorithms. Norm-based total physical and mental component scores are calculated from the raw subscale scores, with higher scores indicating better quality of life. A higher score in the SF-36 subdomains is associated with a high level of functioning and higher quality of life. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Pain-related fear beliefs
The TSK-11 is a widely used tool to measure pain-related fears related to movement and re-injury. It is an adaptation of the original 17-item instrument designed to assess fear of movement or re-injury excluding the 4 original reverse-scored items that were found to have small item-to-total score correlations. The adapted score is an 11-item tool that asks respondents to rate each item on a 4-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The TSK-11 is a reliable and valid measure of fear of movement or re-injury in patients with chronic pain. It has internal consistency, reliability and convergent validity with a Cronbach's α of 0.80 for the total score (Woby et al., 2005). The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Measured: Baseline to nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start17 Aug 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Education Research Foundation (HERF)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aadil Omer, PhD scholar, Principal investigator, Tehran University of Medical Sciences, IranBehrouz Attarbashi Moghadam, PhD, Study chair, Tehran University of Medical Sciences, IranAzadeh Shadmehr, PhD, Study chair, Tehran University of Medical Sciences, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967780
- Sponsor's protocol ID
- IR.TUMS.FNM.REC.1402.060
- Status last verified
- Feb 2024
- First submitted
- 4 Jul 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open Heart Surgery Patients With Forward Head Posture With and Without Perioperative Therapeutic Exercise on Craniovertebral Angle, Pulmonary Function, Balance and Quality of Life
- ClinicalTrials.gov ID
- NCT05967780
- Acronym / sponsor ID
- IR.TUMS.FNM.REC.1402.060
- Conditions
- Cardiac Rehabilitation
- Keywords
- Balance, Craniovertebral angle, Forward head posture, Open heart surgery, Pulmonary function, Quality of life, Strengthening, Stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Health Education Research Foundation (HERF)University, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Aug 2023 (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.
Comparison of open heart surgery patients with forward head posture with and without perioperative therapeutic exercise on craniovertebral angle, pulmonary function, balance and quality of life
Detailed description
Open heart surgery is at high risk of postoperative complications including pulmonary disorders, balance dysfunction and affects quality of life. These complications contribute to morbidity and mortality and increase hospitalization stay and its associated costs. The high prevalence of forward head posture (FHP) in the community is also associated with stated complications like pulmonary disorders, balance dysfunction and affecting quality of life. This close association of these complications in a person with forward head posture undergoing open heart surgery may further heighten the risks. The aim of this study is to evaluate the effects of therapeutic exercises on craniovertebral angle, pulmonary disorders, static and dynamic balance and quality of life in open heart surgery patient having forward head posture. This study will be a prospective, parallel-group, allocation concealment, randomized control, patient and assessor blind trial. Patients (n=53) who undergo open heart surgery via median sternotomy with forward head posture will be recruited from a cardiac hospital. Participants will be divided into three groups. Participants with FHP will be randomized into two groups; 1) patients with FHP will receive standard cardiac rehab protocol, 2) patients with FHP will receive standard cardiac rehab protocol with therapeutic exercise for forward head posture, and 3) participants without FHP will receive standard cardiac rehabilitation. The intervention group will receive a combination of stretching and strengthening exercises (including sternocleidomastoid stretch, pectoralis stretch, the supine chin tuck, and scapular retraction) for forward head posture with standard cardiac rehabilitation. The outcome measures will be craniovertebral angle, pulmonary parameters, neck disability index, functional difficulties questionnaire, single-leg stance test, forward reach test, health-related quality of life (SF-36), and Tampa scale for kinesiophobia. Repeated measures analysis of variance will be taken to test the hypothesis and to evaluate the change from baseline (4 weeks before surgery) to one day before surgery, after surgery before discharge and 4 weeks after discharge from the hospital in the intervention group compared with the standard-care group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Patients with FHP receiving standard cardiac rehabilitation | Active comparator | Other: Group A: Patients with FHP receiving standard cardiac rehabilitationConsenting participants in this group will receive a standard cardiac rehabilitation protocol. |
| Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises | Experimental | Other: Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercisesThe participants who give consent will receive standard cardiac rehabilitation protocol (as Group A) with therapeutic exercise in the intervention group. |
| Group C: Patients without FHP receiving standard cardiac rehabilitation | Active comparator | Other: Group C: Patients without FHP receiving standard cardiac rehabilitationThe participants without forward head posture will be included in this group and will receive same standard cardiac rehabilitation as the participants in group A. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Craniovertebral angle < 50 degrees (included in Group A \& B), Craniovertebral angle ≥ 50 degree (included in Group C)
- First elective coronary artery bypass graft surgery, valve replacement, or both through a median sternotomy
- Extubated within 6 hours after surgery
Key exclusion criteria (11 listed)
- Subjects with a history of surgery or any diagnosed pathology or clinical deformity or any musculoskeletal injury within the last six months to the spine or thorax or shoulder or lower extremity
- Any comorbid lung disease
- Patients having angina pectoris while doing therapeutic exercises
- Neurological dis¬orders, neuromuscular disorders, psychiatric, dizziness and blurred vision
- Inability to stand or walk independently
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 |
|---|---|---|
| Group A: Patients with FHP receiving standard cardiac rehabilitationConsenting participants in this group will receive a standard cardiac rehabilitation protocol that includes preoperative education and post-operative exercises, chest physiotherapy, functional mobility and care. Phase 1 begins after the patient has been considered clinically compensated due to the optimization of the clinical treatment and/or the use of an interventional procedure. In this phase, a combination of low-intensity physical exercise (that includes range of motion exercises for upper \& lower extremities + progressive mobilization from sitting on bedside to walking short distance and up to stair climbing), incentive spirometry exercise, percussions, breathing exercises and effective coughing exercises. | Other | Group A: Patients with FHP receiving standard cardiac rehabilitation |
| Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercisesThe participants who give consent will receive standard cardiac rehabilitation protocol (as Group A) with therapeutic exercise in the intervention group. Therapeutic exercises will be delivered to the participant by treating physiotherapist in physical, verbal and written formats as individualized sessions on the ward 4 weeks before the surgery and keep him doing exercises under supervision while staying in the ward before surgery. A log will be provided to measure performance to ensure program compliance. After discharge from the hospital, the patient will continue exercises at home as performed and guided physically by the therapist and also in the exercises manual and flyer given to the patient. Patients will be instructed to follow therapeutic exercise for 4 weeks pre-operatively and 4 weeks postoperatively after discharge from the hospital. | Other | Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises |
| Group C: Patients without FHP receiving standard cardiac rehabilitationThe participants without forward head posture will be included in this group and will receive same standard cardiac rehabilitation as the participants in group A. | Other | Group C: Patients without FHP receiving standard cardiac rehabilitation |
Primary outcome
Craniovertebral angle
Time frame: Baseline to nine weeks
For measuring the angle, the reflective markers will be placed on the tragus of the ear and spinous process of the C7. The participant will be asked to stand and maintain her usual upright posture with her arms resting at the sides, and looking straight ahead. The photos will be captured by a digital camera. The camera will be positioned on a tripod 50 cm away from the participant. The axis of the lens of the camera will be placed orthogonal to the sagittal plane of the participant at the level of the shoulder. The photos will be taken repeatedly so that the participant was not exactly aware of the actual time of photography. The craniovertebral angle will be calculated by image. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Forced Vital Capacity (FVC)
Time frame: Baseline to nine weeks
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Forced Expired Volume in one second (FEV1)
Time frame: Baseline to nine weeks
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Forced Expired Volume in one second/Forced Vital Capacity (FEV1/FVC) ratio
Time frame: Baseline to nine weeks
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Peak expiratory flow (PEF)
Time frame: Baseline to nine weeks
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
25% of the Force Expiratory Flow (FEF25)
Time frame: Baseline to nine weeks
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
75% of the Force Expiratory Flow (FEF75)
Time frame: Baseline to nine weeks
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Average flow between 25% and 75% of the Force Expiratory Flow (FEF25-75)
Time frame: Baseline to nine weeks
Spirometry is the term for basic lung function tests that measure the amount of air exhaled and inhaled. There are three basic related measurements: volume, time, and flow. Spirometry is objective, non-invasive, sensitive to early changes and reproducible. With the availability of portable measuring devices, it can be performed almost anywhere and by anyone with the right training. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Standing balance
Time frame: Baseline to nine weeks
The Single Leg Stance Test (SLST) is used to assess static balance performance which requires the participant to stand barefoot on their right or left leg (donor's leg) and hold the contralateral leg in approximately 45 degrees of hip flexion and 90 degrees of knee flexion. They are instructed to cross their arms over the chest. The assessor uses a digital chronometer to measure the amount of time patients are able to stand on a single limb. The test ends when the patient's legs touch each other, the non-stance leg touches the floor, or the arms move from the starting position. This process is repeated three times with eyes open and three times with eyes closed. A two-minute rest period between attempts is considered to prevent fatigue. The average of the three trials is calculated separately. The participants will be assessed at baseline, one day before surgery (±1 day) and 4 weeks post-discharge (±3 days).
Dynamic balance
Time frame: Baseline to nine weeks
The Functional Reach Test (FRT) is widely used as a dynamic measure of balance and is a reliable measure of balance for clinical assessment of instability. Participants are asked to stand with their dominant side adjacent to a wall and raise their arm to shoulder height. They are then asked to reach out as far forward as possible while maintaining a firm base of support. A tape measure is attached horizontally to the wall, and the maximum reach distance is recorded as the farthest point of the third metacarpophalangeal joint from the initial (standing) position. In other words, the measures the maximum distance the participants can reach forward from a standing static position. Three trials are performed and the mean value is recorded. The participants will be assessed at baseline, one day before surgery (±1 day) and 4 weeks post-discharge (±3 days).
Disability
Time frame: Baseline to nine weeks
Howard Vernon developed the Neck Disability Index (NDI) in 1989. The Neck Disability Index is now a standard tool to measure self-reported disability due to neck pain. This tool has 10 items and each score from 0 to 5. 50 is the maximum score. To get a percentage score, the score obtained is multiplied by two. The average of all other items is then added to the completed items, if a respondent will not answer one or other question,. NDI is a commonly used tool to measure disability in individuals with forward head posture. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Functional status
Time frame: Baseline to nine weeks
The Functional Difficulties Questionnaire measures the functional status of patients following cardiac surgery, with special emphasis on upper extremity and trunk function in patients following median sternotomy. The questionnaire asks patients to rate the difficulty they would experience performing a series of 13 functional upper extremity and trunk tasks. Specifically, patients are required to place a mark along a 10-cm line, with anchors to the left and right of the line, respectively indicating 'no difficulty' and 'maximum difficulty'. For the activities that participants cannot complete when completing the questionnaire, they are required to recall they performed the tasks last time. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Health related Quality of life
Time frame: Baseline to nine weeks
Health related quality of life is assessed by SF-36, a common measure used to assess eight domains including physical functioning, role physical functioning, role emotional functioning, mental health, vitality, social functioning, bodily pain and general health. All scale or single-item measurements range in score from 0 to 100 and are managed by interview. The raw subscale scores are converted to 'norm-based' scores using published algorithms. Norm-based total physical and mental component scores are calculated from the raw subscale scores, with higher scores indicating better quality of life. A higher score in the SF-36 subdomains is associated with a high level of functioning and higher quality of life. The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
Pain-related fear beliefs
Time frame: Baseline to nine weeks
The TSK-11 is a widely used tool to measure pain-related fears related to movement and re-injury. It is an adaptation of the original 17-item instrument designed to assess fear of movement or re-injury excluding the 4 original reverse-scored items that were found to have small item-to-total score correlations. The adapted score is an 11-item tool that asks respondents to rate each item on a 4-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The TSK-11 is a reliable and valid measure of fear of movement or re-injury in patients with chronic pain. It has internal consistency, reliability and convergent validity with a Cronbach's α of 0.80 for the total score (Woby et al., 2005). The participants will be assessed at baseline, one day before surgery (±1 day), after surgery before discharge (7th postoperative day) (±1 day) and 4 weeks post-discharge (±3 days).
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 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Aadil Omer, PhD scholar principal investigator
Tehran University of Medical Sciences, Iran
Behrouz Attarbashi Moghadam, PhD study chair
Tehran University of Medical Sciences, Iran
Azadeh Shadmehr, PhD study chair
Tehran University of Medical Sciences, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: Patients with FHP receiving standard cardiac rehabilitation, Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises and Group C: Patients without FHP receiving standard cardiac rehabilitation in people with Cardiac Rehabilitation, run by Health Education Research Foundation (HERF) at 1 site in Pakistan.
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 3 inclusion and 11 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 28 Feb 2024. 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 Pakistan. 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?
Craniovertebral angle (time frame: Baseline to nine weeks). The study lists 14 primary outcomes in all. 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 28 Feb 2024.