Cardiovascular DiseasesNDNCT07803120
Effects of External Upper Limb Loading on Gait and Trunk Muscle Activity in Cardiac Rehabilitation Patients
An observational study of Cardiovascular Diseases and Cardiac Rehabilitation, run by Pomeranian University in Slupsk at 1 site in Poland.
Trial summary
This study examines how external loading applied to the upper limbs affects gait parameters and the activity of selected trunk- and pelvis-stabilizing muscles (erector spinae, gluteus medius, tensor fasciae latae, external oblique) in patients undergoing cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Cardiac Rehabilitation, Gait Abnormality
- What is being tested?
- External Upper Limb Loading During Treadmill Walking
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 15 May 2026to 31 Dec 2026
- Phase
- Observational
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are adult patients referred to a hospital-based cardiac rehabilitation program (Wojewódzki Szpital Specjalistyczny w Słupsku) following a cardiac event or procedure, who are medically stable and undergoing supervised outpatient/inpatient cardiac rehabilitation. Assessments are conducted by the biomechanics laboratory (Pomeranian University in Słupsk).
Who may be able to join
- Age ≥18 and ≤80 years
- Referred to cardiac rehabilitation following a cardiac event or procedure
- Medically stable, classified as NYHA class I-II
- Able and willing to provide informed consent
- Willing and able to complete the study procedures
- Able to safely perform treadmill walking and exercise testing
- No cardiological or pulmonological contraindications to exercise
- No limb deformities or gait pathology identified on clinical interview
Who cannot join
- Unstable coronary artery disease, recent myocardial infarction (<4 weeks), or recent revascularization (<4 weeks)
- Heart failure NYHA class III-IV
- Uncontrolled hypertension
- Cardiac arrhythmias
- Neurological or neurodegenerative disease
- Acute lower-limb or spinal injury, musculoskeletal deformity, or significant pain affecting gait
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- Diabetes mellitus with hypoglycemia tendency
- Pregnancy
- BMI >35 kg/m²
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomechanical, Electromyographic, and Baropodometric Assessment of Gait Parameters and Trunk-Stabilizing Muscle Activity at Baseline and Under Unilateral and Bilateral Upper Limb Loading in Patients Undergoing Cardiac Rehabilitation
This study examines how external loading applied to the upper limbs affects gait parameters and the activity of selected trunk- and pelvis-stabilizing muscles (erector spinae, gluteus medius, tensor fasciae latae, external oblique) in patients undergoing cardiac rehabilitation. Participants are medically stable adults (18-80 years) referred to cardiac rehabilitation following a cardiac event or procedure, meeting NYHA class I-II criteria, with no unstable coronary disease, uncontrolled hypertension, neurological disease, or other exclusion criteria.
Participants will walk on a treadmill at 1 km/h, 3 km/h and 5 km/h under three conditions: without load, with unilateral upper-limb loading, and with bilateral upper-limb loading. Muscle activity will be recorded using surface electromyography (sEMG), and plantar pressure/gait parameters will be recorded simultaneously using baropodometry integrated into the treadmill. The procedure is non-invasive, does not breach the skin, and does not involve any additional intervention beyond standard rehabilitation. To contextualize functional outcomes, previously collected exercise stress test results (performed independently by the treating physician before and after cardiac rehabilitation, as part of routine clinical care) will be retrieved from participants' medical records for comparison; this is a retrospective data comparison, not an additional study intervention.
No financial compensation is provided. Each participant will receive an individual report of their sEMG and gait findings with professional interpretation. Risks are minimal and limited to transient skin irritation from electrodes and mild, temporary muscle fatigue or soreness typical of moderate exercise. Participants may withdraw at any time.
Read the detailed description
Study Design and Rationale This is a prospective, observational biomechanical and neuromuscular study evaluating the effect of external upper-limb loading (unilateral, dominant and non-dominant side, and bilateral) on gait parameters and the activity of selected trunk- and pelvis-stabilizing muscles in patients undergoing cardiac rehabilitation. Existing literature on muscle activity during loaded walking is limited, and the extent and pattern of these changes are not yet well characterized. This study aims to address that gap and provide data relevant to rehabilitation practice, including load standardization in physiotherapy.
Participants 50-60 adults (18-80 years) referred to cardiac rehabilitation following a cardiac event or procedure (including patients several years post-event), medically stable and classified as NYHA class I-II. Recruitment uses stratified random sampling, with strata based on sex and age to ensure balanced representation. Exclusion criteria include unstable coronary artery disease, recent myocardial infarction (<4 weeks), NYHA class III-IV heart failure, uncontrolled hypertension, cardiac arrhythmias, neurological or neurodegenerative disease, acute lower-limb or spinal injury, gait pathology, poorly controlled diabetes with hypoglycemia risk, pregnancy, BMI >35 kg/m², and lack of consent.
Procedures Participants complete a health/medical history questionnaire followed by a preliminary diagnostic assessment of physical capacity. During the main protocol, participants walk on a treadmill at 1 km/h, 3 km/h and 5 km/h under three loading conditions (no load, unilateral, bilateral), while sEMG records activity of the erector spinae, gluteus medius, tensor fasciae latae, and external oblique muscles, and baropodometry (integrated into the treadmill) simultaneously records plantar pressure and gait parameters.
Additionally, exercise stress test results obtained by the participant's physician before and after cardiac rehabilitation - performed independently of this study as part of routine clinical care - are retrieved from medical records by a research team member with institutional authorization to access patient data, and compared with the sEMG/gait findings. No stress testing is performed by the research team as part of this protocol.
Ethical and Regulatory Compliance The protocol has been reviewed and approved by the relevant bioethics committee. Written informed consent is obtained from all participants prior to participation. Access to participants' medical records (stress test results) is conducted under existing institutional authorization held by a research team member.
- Conditions
- Cardiovascular Diseases, Cardiac Rehabilitation, Gait Abnormality, Muscle Contraction, Exercise Tolerance
- Being tested
- External Upper Limb Loading During Treadmill Walking
- Keywords
- gait analysis, surface electromyography, external loading, cardiac rehabilitation, trunk and pelvic muscle activation, treadmill walking, upper limb loading
- Medical subject headings
- Cardiovascular Diseases, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Upper Limb Loading During Treadmill WalkingOther
Participants walk on a treadmill at controlled speeds (3 km/h and 5 km/h) under three conditions: without external load, with unilateral upper-limb loading (dominant and non-dominant side), and with bilateral upper-limb loading. Gait parameters and lower-limb/trunk muscle activity are recorded simultaneously via surface electromyography (sEMG) and baropodometry integrated into the treadmill system. This is a non-invasive assessment procedure, not a therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation Patients | Adult patients (N=60) (18-80 years) referred to cardiac rehabilitation following a cardiac event or procedure, medically stable and classified as NYHA class I-II. Each participant is assessed at two time points: at the start of cardiac rehabilitation (Day 1) and approximately 20 rehab-days later, following completion of the rehabilitation program. At each session, participants walk on a treadmill at 3 km/h and 5 km/h under three loading conditions (no load, unilateral upper-limb loading, bilateral upper-limb loading), while gait parameters and trunk/pelvic muscle activity are recorded. Receives: Other: External Upper Limb Loading During Treadmill Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sEMG-Derived Neuromuscular Asymmetry Index
Asymmetry index from normalized RMS sEMG amplitude of erector spinae, gluteus medius, tensor fasciae latae, and external oblique, dominant vs. non-dominant side during unloaded treadmill walking. Expressed as a percentage; 0% indicates perfect symmetry, higher values greater asymmetry.
Unit of Measure: percentage · Measure Type: Mean
Measured: Day 1 of cardiac rehabilitation (baseline)
Mean Plantar Pressure Distribution Asymmetry Index
Asymmetry index from baropodometric plantar pressure distribution, dominant vs. non-dominant lower limb during unloaded treadmill walking. Expressed as a percentage; 0% indicates perfect symmetry, higher values greater asymmetry.
Unit of Measure: percentage · Measure Type: Mean
Measured: Day 1 of cardiac rehabilitation (baseline)
Mean Spatiotemporal Gait Asymmetry Index
Asymmetry index from spatiotemporal gait parameters (step length, stance and swing phase duration), dominant vs. non-dominant lower limb during unloaded treadmill walking. Expressed as a percentage; 0% indicates perfect symmetry, higher values greater asymmetry.
Unit of Measure: percentage · Measure Type: Mean
Measured: Day 1 of cardiac rehabilitation (baseline)
Secondary outcomes (3)
Mean Change from Baseline in sEMG-Derived Neuromuscular Asymmetry Index After Rehabilitation
Mean change from baseline (Day 1) to the end of the rehabilitation program (after 20 sessions, approximately 30 days) in the sEMG-derived neuromuscular asymmetry index (normalized RMS sEMG amplitude of erector spinae, gluteus medius, tensor fasciae latae, and external oblique), during unloaded treadmill walking at 1, 3, and 5 km/h. Expressed in percentage points; a negative value indicates reduced asymmetry.
Unit of Measure: percentage points · Measure Type: Mean
Measured: After completion of 20 rehabilitation sessions (approximately 30 days)
Mean Change from Baseline in Plantar Pressure Distribution Asymmetry Index After Rehabilitation
Mean change from baseline (Day 1) to the end of the rehabilitation program (after 20 sessions, approximately 30 days) in the baropodometric plantar pressure distribution asymmetry index, during unloaded treadmill walking at 1, 3, and 5 km/h. Expressed in percentage points; a negative value indicates reduced asymmetry.
Unit of Measure: percentage points · Measure Type: Mean
Measured: After completion of 20 rehabilitation sessions (approximately 30 days)
Mean Change from Baseline in Spatiotemporal Gait Asymmetry Index After Rehabilitation
Mean change from baseline (Day 1) to the end of the rehabilitation program (after 20 sessions, approximately 30 days) in the spatiotemporal gait asymmetry index (step length, stance and swing phase duration), during unloaded treadmill walking at 1, 3, and 5 km/h. Expressed in percentage points; a negative value indicates reduced asymmetry.
Unit of Measure: percentage points · Measure Type: Mean
Measured: After completion of 20 rehabilitation sessions (approximately 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start15 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian University in Slupsk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wojciech Nawos-Wysocki, MSc PT, Principal investigator, Pomeranian University in SłupskAgnieszka Grochulska, PhD, MSc PT, Study director, Pomeranian University in Słupsk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803120
- Sponsor's protocol ID
- K01
- Acronym
- ND
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data supporting the specific results reported in each peer-reviewed publication arising from this study will be made available, typically as supplementary material accompanying the relevant article. Data are shared on a per-publication basis rather than as a complete raw dataset