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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06287996
Other study ID # 23MMHIS503e NA
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 23, 2024
Est. completion date August 1, 2024

Study information

Verified date February 2024
Source Mackay Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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 research subjects are cardiology outpatients at two medical centers in northern China (Taipei and New Taipei City). It is expected to recruit 76 research subjects (38 in the control group and 38 in the experimental group). Pre-test data collection includes basic personal information, subjective sleep quality and fatigue level questionnaires, and wearing an actigraph on the wrist. Patients were assigned to an experimental group and a control group based on random assignment results. The control group received routine care and wore an actigraph. In addition to routine care and wearing an actigraph, the experimental group also received warm foot baths for 4 weeks, one hour before going to bed every night. (7-9PM), the temperature is 42°C for 20 minutes, and the water depth is 10 cm above the ankle joint. Both groups receive weekly phone calls to confirm wearing the actigraph and performing warm water foot baths. Post-test data were collected in the second and fourth weeks, including subjective sleep quality and fatigue level questionnaires. After the four weeks, the researchers collected and analyzed physiological measurements: sleep quality-sleep time and efficiency, and heart rate variability index. Research tools include basic information sheets, actigraphy, warm water foot bath machines, Pittsburgh Sleep Quality Scale, and Piper Fatigue Scale. The collected data were processed and analyzed using SPSS 26.0 statistical software. Warm water foot bath is a local hot compress, which is non-invasive and simple to operate. It has the effect of relieving sleep and fatigue of patients with heart failure. It is suitable for patients with heart failure during hospitalization or at home.We hope it will be helpful to clinical care practice, education and research.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 76
Est. completion date August 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Leg injury or foot wound - Peripheral vascular disease - History of stroke

Study Design


Related Conditions & MeSH terms


Intervention

Other:
footbath and actigraphy
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
Device:
actigraphy
Wearing an actigraphy for 4 weeks

Locations

Country Name City State
Taiwan Mackay Memorial Hospital Taipei Zhongshan

Sponsors (1)

Lead Sponsor Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other heart rate variability Fourth week after intervention
Primary sleep quality Before intervention and the 2nd and 4th week after intervention
Secondary fatigue Before intervention and the 2nd and 4th week after intervention
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