Effects of External Upper Limb Loading on Gait and Trunk Muscle Activity in Cardiac Rehabilitation Patients

NCT07803120 | Active Not Recruiting

• 1 other identifier: K01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Diseases; Cardiac Rehabilitation; Gait Abnormality; Muscle Contraction; Exercise Tolerance

Keywords

gait analysis; surface electromyography; external loading; cardiac rehabilitation; trunk and pelvic muscle activation; treadmill walking; upper limb loading

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Day 1 of cardiac rehabilitation (baseline)

Secondary Outcomes (3)

• Mean Change from Baseline in sEMG-Derived Neuromuscular Asymmetry Index After Rehabilitation

  After completion of 20 rehabilitation sessions (approximately 30 days)

• Mean Change from Baseline in Plantar Pressure Distribution Asymmetry Index After Rehabilitation

  After completion of 20 rehabilitation sessions (approximately 30 days)

• Mean Change from Baseline in Spatiotemporal Gait Asymmetry Index After Rehabilitation

  After completion of 20 rehabilitation sessions (approximately 30 days)

Study Arms (1)

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.

Other: External Upper Limb Loading During Treadmill Walking

Interventions

External Upper Limb Loading During Treadmill Walking OTHER

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.

Cardiac Rehabilitation Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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
• Diabetes mellitus with hypoglycemia tendency
• Pregnancy
• BMI \>35 kg/m²
• Lack of informed consent

Sponsors & Collaborators

• Pomeranian University in Slupsk: lead

Study Sites (1)

Wojewódzki Szpital Specjalistyczny w Słupsku

Słupsk, 76-200, Poland

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wojciech Nawos-Wysocki, MSc PT

  Pomeranian University in Słupsk

  PRINCIPAL INVESTIGATOR

• Agnieszka Grochulska, PhD, MSc PT

  Pomeranian University in Słupsk

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: September 3, 2026
• Study Start: May 15, 2026
• Primary Completion: August 31, 2026
• Study Completion: August 31, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data underlying each publication will be made available at the time of publication of that article, as supplementary material.
• Access Criteria: De-identified data supporting published results will be provided as supplementary files with each publication. Data beyond what is published may be requested from the corresponding author for legitimate research purposes and will be reviewed on a case-by-case basis.

Locations

PL (1)