SternotomyNCT07906873
Impact of Pre- and Early Post-operative Isometric Handgrip Training on Functional Capacity and Autonomic Function After Sternotomy
A study testing Isometric Handgrip Training using analog hand dynamometer in people with Sternotomy and Functional Capacity, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of isometric handgrip (IHG) training on functional capacity and autonomic function before and after sternotomy. Open-heart surgery causes significant physiological stress, functional decline, and autonomic dysfunction. Read more about this study
- Who is it for?
- Ages 40 to 55 years, men only
- Conditions the study is for
- Sternotomy, Functional Capacity, Autonomic Function
- What is being tested?
- Isometric Handgrip Training using analog hand dynamometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Oct 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged 40-55 years
- Ejection fraction (EF) >40% as documented by pre-operative echocardiography
- Patients undergoing elective open-heart surgery via median sternotomy (e.g., CABG, single or double valve replacement)
- Cognitive ability to follow exercise instructions
- Sternal stability with no evidence of post-operative sternal complications
- Hemodynamically stable for at least 24-48 hours postoperatively
- Stable cardiac rhythm (sinus rhythm or well-controlled atrial fibrillation with resting heart rate <100 bpm)
Who cannot join
- Sternal infection or wound complications
- Medically unstable postoperative condition preventing safe participation in exercise training
- Musculoskeletal or cognitive impairments limiting ability to participate in exercise training
- Previous cardiac surgery
- Anemia
- Uncontrolled hypertension
- Cardiac arrhythmia or angina
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Heart institute
Giza
Shymaa Maaty, PhD in physical therapy, +20 11 16432548, shymaamahmoudmaaty@gmail.comshymaamahmoudmaaty@gmail.com
About this study
This study aims to evaluate the effect of isometric handgrip (IHG) training on functional capacity and autonomic function before and after sternotomy. Open-heart surgery causes significant physiological stress, functional decline, and autonomic dysfunction. Patients undergoing sternotomy will be assessed for 6-minute walk test (6MWT), heart rate recovery (HRR), hemodynamic stability, rate pressure product (RPP), handgrip strength, and anxiety level. The intervention group will perform IHG training at 30% of maximal voluntary contraction, 2 minutes contraction per hand followed by 1 minute rest, for 20 minutes daily, 2-3 days before surgery and 24 hours once the patient is stabilized after sternotomy, in addition to standard care sessions (breathing and mobilization exercises). This low-cost, safe intervention aims to improve early cardiac rehabilitation, reduce complications, and enhance functional recovery.
- Conditions
- Sternotomy, Functional Capacity, Autonomic Function
- Being tested
- Isometric Handgrip Training using analog hand dynamometer, Standard care including breathing and motor exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Handgrip Training using analog hand dynamometerOther
Isometric hand grip training performed using an analog hand dynamometer (baseline type) at 30% of maximal voluntary contraction. Protocol: 2 minutes contraction per hand followed by 1 minute rest, total duration 20 minutes per session, once daily for 2-3 days before sternotomy and starting 24 hours after surgery once the patient is hemodynamically stabilized. Performed in addition to standard physiotherapy.
Standard care including breathing and motor exercisesOther
Standard care: performed twice daily (morning and afternoon) for control group and once daily (afternoon) for IHGT group, 20 min per session: 1) Respiratory exercises (10 min): passive manual expiratory therapy 2 sets x 10 reps, fractional inspiration in times 3 sets x 10 reps, diaphragmatic breathing 3 sets x 10 reps. 2) Motor exercises (10 min): active exercises for upper and lower limbs, stationary walking 2-3 min, overground ambulation 3 min, and gradual stair training 1-2 flights (5-10 steps) based on hemodynamic stability.
| Study group | Role | What they receive |
|---|---|---|
| Isometric hand grip training for Sternotomy patients | Experimental | Patients will perform isometric hand grip training at 30% of maximal voluntary contraction, 2 minutes per hand followed by 1 minute rest, for 20 minutes daily, 2-3 days before surgery and 24 hours after sternotomy once stabilized, in addition to standard breathing and mobilization exercises. Receives: Other: Isometric Handgrip Training using analog hand dynamometer; Other: Standard care including breathing and motor exercises |
| Standard care | Active comparator | Patients will receive standard care including breathing exercises and early mobilization exercises, before and after sternotomy. Receives: Other: Standard care including breathing and motor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walk Test - Functional Capacity
Functional exercise capacity assessed by total distance walked in meters during 6-Minute Walk Test performed in a 30-meter corridor at self-paced speed . Heart rate, blood pressure, oxygen saturation and perceived exertion recorded before and after test for safety.
Measured: Baseline 2-3 days before surgery and at hospital discharge up to 7 days postoperatively
Secondary outcomes (6)
Heart Rate Recovery
Difference between peak heart rate after exercise and heart rate after 1 minute of recovery as indicator of autonomic function
Measured: Baseline 2-3 days before surgery, day before surgery, 24-48 hours after surgery, and at discharge up to 7 days
Hand Grip Strength
Maximal hand grip strength measured by calibrated handheld dynamometer in standardized seated position with elbow flexed at 90 degrees, highest value of 3 maximal voluntary contractions recorded in kilograms
Measured: Baseline 2-3 days before surgery, day before surgery, 24-48 hours after surgery, and at discharge up to 7 days
Heart rate
Heart rate measured at peak exercise and after one minute of recovery, measured by pulse oximetry, as raw Values for Hemodynamic Response, Recorded in bpm
Measured: Baseline 2-3 days before surgery, day before surgery, 24-48 hours after surgery, and at discharge up to 7 days
Resting and post-exercise Blood Pressure
blood pressure measured by aneroid sphygmomanometer before and after exercise, Measured in mmHg
Measured: Baseline 2-3 days before surgery and at hospital discharge up to 7 days postoperatively
Rate Pressure Product
Rate Pressure Product calculated as heart rate multiplied by systolic blood pressure as indicator of myocardial oxygen consumption, Recorded in mmHg.bpm
Measured: Baseline 2-3 days before surgery and at hospital discharge up to 7 days postoperatively
Anxiety
Anxiety level assessed by Visual Analogue Scale for Anxiety VAS-A, 10 cm horizontal line from no anxiety to extreme anxiety
Measured: Baseline 2-3 days before surgery, day before surgery, 24-48 hours after surgery, and at discharge up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start16 Oct 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SternotomyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Model description
- Randomized controlled trial with two parallel arms, participants randomly assigned to either isometric handgrip training plus standard care or standard care alone
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mostafa Abd El-salam Meligy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906873
- Sponsor's protocol ID
- CairoU-salma-2026
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre- and Early Post-operative Isometric Handgrip Training on Functional Capacity and Autonomic Function After Sternotomy
- ClinicalTrials.gov ID
- NCT07906873
- Acronym / sponsor ID
- CairoU-salma-2026
- Conditions
- Sternotomy, Functional Capacity, Autonomic Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Oct 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Oct 2026 (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.
This study aims to evaluate the effect of isometric handgrip (IHG) training on functional capacity and autonomic function before and after sternotomy. Open-heart surgery causes significant physiological stress, functional decline, and autonomic dysfunction. Patients undergoing sternotomy will be assessed for 6-minute walk test (6MWT), heart rate recovery (HRR), hemodynamic stability, rate pressure product (RPP), handgrip strength, and anxiety level. The intervention group will perform IHG training at 30% of maximal voluntary contraction, 2 minutes contraction per hand followed by 1 minute rest, for 20 minutes daily, 2-3 days before surgery and 24 hours once the patient is stabilized after sternotomy, in addition to standard care sessions (breathing and mobilization exercises). This low-cost, safe intervention aims to improve early cardiac rehabilitation, reduce complications, and enhance functional recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two parallel arms, participants randomly assigned to either isometric handgrip training plus standard care or standard care alone
| Arm | Type | Receives |
|---|---|---|
| Isometric hand grip training for Sternotomy patients | Experimental | Other: Isometric Handgrip Training using analog hand dynamometer, Other: Standard care including breathing and motor exercisesPatients will perform isometric hand grip training at 30% of maximal voluntary contraction, 2 minutes per hand followed by 1 minute rest, for 20 minutes daily, 2-3 days before surgery and 24 hours after sternotomy once stabilized, in addition to standard breathing and mobilization exercises. |
| Standard care | Active comparator | Other: Standard care including breathing and motor exercisesPatients will receive standard care including breathing exercises and early mobilization exercises, before and after sternotomy. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male patients aged 40-55 years
- Ejection fraction (EF) >40% as documented by pre-operative echocardiography
- Patients undergoing elective open-heart surgery via median sternotomy (e.g., CABG, single or double valve replacement)
- Cognitive ability to follow exercise instructions
- Sternal stability with no evidence of post-operative sternal complications
Key exclusion criteria (7 listed)
- Sternal infection or wound complications
- Medically unstable postoperative condition preventing safe participation in exercise training
- Musculoskeletal or cognitive impairments limiting ability to participate in exercise training
- Previous cardiac surgery
- Anemia
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 |
|---|---|---|
| Isometric Handgrip Training using analog hand dynamometerIsometric hand grip training performed using an analog hand dynamometer (baseline type) at 30% of maximal voluntary contraction. Protocol: 2 minutes contraction per hand followed by 1 minute rest, total duration 20 minutes per session, once daily for 2-3 days before sternotomy and starting 24 hours after surgery once the patient is hemodynamically stabilized. Performed in addition to standard physiotherapy. | Other | Isometric hand grip training for Sternotomy patients |
| Standard care including breathing and motor exercisesStandard care: performed twice daily (morning and afternoon) for control group and once daily (afternoon) for IHGT group, 20 min per session: 1) Respiratory exercises (10 min): passive manual expiratory therapy 2 sets x 10 reps, fractional inspiration in times 3 sets x 10 reps, diaphragmatic breathing 3 sets x 10 reps. 2) Motor exercises (10 min): active exercises for upper and lower limbs, stationary walking 2-3 min, overground ambulation 3 min, and gradual stair training 1-2 flights (5-10 steps) based on hemodynamic stability. | Other | Isometric hand grip training for Sternotomy patients, Standard care |
Primary outcome
Six Minute Walk Test - Functional Capacity
Time frame: Baseline 2-3 days before surgery and at hospital discharge up to 7 days postoperatively
Functional exercise capacity assessed by total distance walked in meters during 6-Minute Walk Test performed in a 30-meter corridor at self-paced speed . Heart rate, blood pressure, oxygen saturation and perceived exertion recorded before and after test for safety.
6 secondary outcomes
Heart Rate Recovery
Time frame: Baseline 2-3 days before surgery, day before surgery, 24-48 hours after surgery, and at discharge up to 7 days
Hand Grip Strength
Time frame: Baseline 2-3 days before surgery, day before surgery, 24-48 hours after surgery, and at discharge up to 7 days
Heart rate
Time frame: Baseline 2-3 days before surgery, day before surgery, 24-48 hours after surgery, and at discharge up to 7 days
Resting and post-exercise Blood Pressure
Time frame: Baseline 2-3 days before surgery and at hospital discharge up to 7 days postoperatively
Rate Pressure Product
Time frame: Baseline 2-3 days before surgery and at hospital discharge up to 7 days postoperatively
Anxiety
Time frame: Baseline 2-3 days before surgery, day before surgery, 24-48 hours after surgery, and at discharge up to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Related trials for Sternotomy
RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
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Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
Not yet recruitingPhase 4
Superficial Parasternal Block Combined With Rectus Sheath Block for Open Cardiac Surgery
Cardiac Valve Disease, Coronary Heart Disease
Not yet recruiting
Bilateral Pecto-Intercostal Fascial Plane Block for Prevention of Chronic Poststernotomy Pain After CABG
Chronic Poststernotomy Pain
Active, not recruiting
Early Rehabilitation in Patients Following Major Cardiac Surgery: Changes in Functional Capacity and Energy Efficiency in Walking and ADLs.
Cardiac Surgery, Median Sternotomy
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.
National Heart institute
Giza, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Handgrip Training using analog hand dynamometer in people with Sternotomy and Functional Capacity, run by Cairo University at 1 site in Egypt.
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 7 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Minute Walk Test - Functional Capacity (time frame: Baseline 2-3 days before surgery and at hospital discharge up to 7 days postoperatively). 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 Nov 2026.