Sequential Compression Device and Range of Motion Exercises on Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units

NCT ID: NCT07305870

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-28
• Study Completion Date: 2026-06-20

Brief Summary

Objectives of The Study:

1. Assess the effectiveness of sequential compression device on distributive peripheral edema and hemodynamic stability for patients in critical care units.

2. Assess the effectiveness of range of motion on distributive peripheral edema and hemodynamic stability for patients in critical care units.

3. Evaluate the synergic effectiveness of sequential compression device and range of motion on distributive peripheral edema and hemodynamic stability for patients in critical care units

4. Find out the differences between the effectiveness of sequential compression device, range of motion, and synergic effectiveness of both interventions on distributive peripheral edema and hemodynamic stability

5. Find out relationships between the effectiveness of sequential compression device, range of motion, and synergic effectiveness of both interventions with patients' demographic characteristics.

Detailed Description

Globally, approximately (13-20) million people treated in intensive care units (ICUs) each year, where common complications such as edema are due to prolonged immobility and critical illness (Ramadan et al., 2025). Edema refers to accumulation of excess fluid in body tissues, manifesting in multi forms such as cerebral, pulmonary, or ocular edema. Peripheral edema considered one of the most prevalent types, specifically represents to swelling in the limbs (Besharat et al., 2021). It caused by imbalance between oncotic and hydrostatic pressures, leading to increased capillary permeability and fluid accumulation in the interstitial space(Smith et al., 2024).

Danziger et al., (2016)found that hospital mortality was significantly higher in those presenting with peripheral edema (22.2%) compared with those without (12.6%) among 12,778 critically ill patients. Also, the severity of edema at admission correlated with increased mortality risk.

The prevalence of peripheral lower limb edema among older adults in U.S was 20.0%, 19.4%, 19.0%, 19.0%, and 19.1% in 2000, 2004, 2008, 2012, and 2016, respectively. It was significantly associated with clinical, demographic, and lifestyle factors, including obesity, diabetes, hypertension, pain, low physical activity, mobility limitations, advanced age, female sex, minority race, and low socioeconomic status (Besharat et al., 2021).

In Japan, the Ministry of Health, Labor, and Welfare reported an increase in the number of patients with severe motion disabilities, particularly among individuals over 60 years old (Suehiro et al., 2014). Similarly, data from the Health and Retirement Study revealed that chronic peripheral edema affects approximately 19% to 20% of older adults, particularly among women, racial minorities, and individuals with limited mobility (Besharat et al., 2021).

Peripheral edema is a multifactorial and complex condition that affects patients suffering from a various of diseases. Its underlying pathology varies considerably, with common causes including congestive heart failure (CHF), liver disease, vascular conditions such as chronic venous insufficiency, and postoperative surgical complications (Smith et al., 2024).

Conditions

Peripheral Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sequential Compression Device group

Sequential Compression Device (SCD) participants group involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days.

Group Type: ACTIVE_COMPARATOR

Sequential compression device

Intervention Type: DEVICE

Sequential Compression Device (SCD) protocol involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days.

Range of Motion exercises

The Range of Motion (ROM) Exercises program entails 20 minutes of flexion-extension movements for both limbs, conducted in two sessions per day over 5 days. Patients perform passive range of motion exercises for upper extremities including movements of fingers, wrists, elbows, and shoulders, as well as for lower extremities encompassing toe, ankle, knee, and hip movements. In addition control group will receive slandered care which is limps elevation

Group Type: ACTIVE_COMPARATOR

legs exercises

Intervention Type: DEVICE

The Range of Motion (ROM) Exercises program entails 20 minutes of flexion-extension movements for both limbs, conducted in two sessions per day over 5 days. Patients perform passive range of motion exercises for upper extremities including movements of fingers, wrists, elbows, and shoulders, as well as for lower extremities encompassing toe, ankle, knee, and hip movements. In addition control group will receive slandered care which is limps elevation

Interventions

Sequential compression device

Sequential Compression Device (SCD) protocol involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days.

Intervention Type: DEVICE

legs exercises

The Range of Motion (ROM) Exercises program entails 20 minutes of flexion-extension movements for both limbs, conducted in two sessions per day over 5 days. Patients perform passive range of motion exercises for upper extremities including movements of fingers, wrists, elbows, and shoulders, as well as for lower extremities encompassing toe, ankle, knee, and hip movements. In addition control group will receive slandered care which is limps elevation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients who were hospitalized in critical care units.
• Subjects over the age of 18 years.
• Presence of peripheral edema (pitting edema ≥1+ in lower extremities).
• Patients how are hemodynamically stable.
• Patients how are able to tolerate positioning for interventions.

Exclusion Criteria

• Patients with lymphedema.
• Patients with chronic kidney disease.
• patients with presence of deep vein thrombosis, severe peripheral arterial disease, or phlebitis.
• patients with open wounds, ulcers, or skin infections on lower limbs.
• patients with fractures, orthopedic surgery, or joint immobility in lower extremities.
• patients with severe cardiac failure or pulmonary edema.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karbala University

OTHER

Sponsor Role: lead

Responsible Party

Hussein Hamza Jawad

Masters graduate student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hussein H Jawad MGS study principal investigator

Role: PRINCIPAL_INVESTIGATOR

Kerbala health department

Locations

Kerbala health department

Karbala, Center, Iraq

Countries

Iraq

Central Contacts

Hussein H Jawad MGS

Role: CONTACT

Phone: +9647815563674

Email: m13180018@s.uokerbala.edu.iq

Hassan A Athbi Assoc.Prof, Assoc.Prof

Role: CONTACT

Phone: +9647721902514

Email: hasan.abdallh@uokerbala.edu.iq

Other Identifiers

uok.coN.25.099

Identifier Type: -

Identifier Source: org_study_id