Effects of Warm Water Footbath Intervention on Sleep Quality , Fatigue and Heart Rate Variability in Patients With Heart Failure

NCT06287996 | Enrolling By Invitation DMC

• 1 other identifier: 23MMHIS503e NA
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study adopted an experimental research design to explore the effects of a warm water foot bath program on fatigue, sleep, and heart rate variability in patients with heart failure. The subjects of the study were heart failure patients in the cardiology outpatient department. The patients were randomly assigned to the experimental group and the control group. The control group received routine care and wore an actigraph. The experimental group received 4 additional care in addition to routine care and wearing an actigraph. Weekly warm water foot bath, data collection includes subjective sleep quality and fatigue level, physiological measurements: sleep quality-sleep time and efficiency, and heart rate variability index.

Conditions

Footbath; Heart Failure; Sleep Quality; Fatigue; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• sleep quality

  Before intervention and the 2nd and 4th week after intervention

Secondary Outcomes (1)

• fatigue

  Before intervention and the 2nd and 4th week after intervention

Other Outcomes (1)

• heart rate variability

  Fourth week after intervention

Study Arms (2)

Warm water foot-bath and actigraphy

EXPERIMENTAL

Warm water foot-bath and actigraphy

Other: footbath and actigraphy; Device: actigraphy

actigraphy

ACTIVE COMPARATOR

actigraphy

Device: actigraphy

Interventions

footbath and actigraphy OTHER

Receive warm water foot bath for 4 weeks, 1 hour before going to bed every night (7-9PM), temperature 42℃ for 20 minutes, water depth 10cm above the ankle joint and wearing an actigraphy for 4 weeks

Warm water foot-bath and actigraphy

actigraphy DEVICE

Wearing an actigraphy for 4 weeks

Warm water foot-bath and actigraphy; actigraphy

Eligibility Criteria

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

You may qualify if:

• Diagnosed by a cardiologist as suffering from heart failure, NYHA functional class one to three and with a history of reduced ejection fraction (HFrEF, EF ≤ 40%)
• Clear consciousness and able to communicate
• Those who can maintain a sitting position by themselves or with the help of others
• Temperature, hearing and vision are normal

You may not qualify if:

• Leg injury or foot wound
• Peripheral vascular disease
• History of stroke

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memorial Hospital

Taipei, Zhongshan, 104, Taiwan

Location

MeSH Terms

Conditions

Heart Failure; Sleep Initiation and Maintenance Disorders; Fatigue

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 1, 2024
• Study Start: February 23, 2024
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)