NCT07892560

Brief Summary

Sleep disturbances are common among older adults residing in long-term care facilities. Warm-water footbaths may help improve sleep quality; however, different immersion depths may affect the body's response to warming. This study examined the effects of warm-water footbaths at different immersion depths on subjective and objective sleep quality among older adults living in long-term care facilities. A total of 40 older adults aged 65 years or older from six long-term care facilities in southern Taiwan participated in a crossover study. The study compared three conditions: ankle-level footbaths, below-knee footbaths, and routine care without a footbath. During the footbath interventions, participants immersed both feet in water at 42°C for 15 minutes approximately one hour before bedtime. Subjective sleep quality was assessed using the Verran and Snyder-Halpern Sleep Scale, and objective sleep quality was measured using wrist actigraphy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2025

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

2 months

First QC Date

October 11, 2026

Last Update Submit

October 18, 2026

Conditions

Keywords

footbathSleep qualityOlder adultsLong-term care facilitiespassive heating

Outcome Measures

Primary Outcomes (5)

  • Subjective Sleep Quality Measured by the Verran and Snyder-Halpern Sleep Scale

    Subjective sleep quality was assessed using the 15-item Verran and Snyder-Halpern Sleep Scale (VSH). Each item is scored from 0 to 100, with a total score ranging from 0 to 1,500. Higher total scores indicate better subjective sleep quality. The VSH was completed before 9:00 a.m. each morning to assess sleep quality during the previous night. For each study condition, the scores from two consecutive mornings were averaged and compared across the three conditions.

    Over seven consecutive days, from baseline to completion of the interventions, sleep quality was assessed before 9:00 a.m. each morning: once after the baseline night and twice after each two-night condition (ankle-level footbath, routine care, below-kne

  • Total Sleep Time (TST) Measured by Wrist Actigraphy

    Total sleep time (TST) was measured using wrist actigraphy and expressed in minutes. It represents the total time spent asleep during the nighttime sleep period. The device was worn on the nondominant wrist overnight. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. TST values from two consecutive nights under each condition were averaged for analysis.

    Over seven consecutive nights per participant, from baseline to completion of the interventions, total sleep time was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath).

  • Sleep Latency (SL) Measured by Wrist Actigraphy

    Sleep latency (SL) was measured using wrist actigraphy and expressed in minutes. It represents the time from bedtime to sleep onset. The device was worn overnight on the nondominant wrist. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. SL values from two consecutive nights under each condition were averaged for analysis.

    Over seven consecutive nights per participant, from baseline to completion of the interventions, sleep latency was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath).

  • Wake After Sleep Onset (WASO) Measured by Wrist Actigraphy

    Wake after sleep onset (WASO) was measured using wrist actigraphy and expressed in minutes. It represents the total time spent awake after initially falling asleep during the nighttime sleep period. The device was worn overnight on the nondominant wrist. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. WASO values from two consecutive nights under each condition were averaged for analysis.

    Over seven consecutive nights per participant, from baseline to completion of the interventions, wake after sleep onset was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath

  • Sleep Efficiency (SE) Measured by Wrist Actigraphy

    Sleep efficiency (SE) was measured using wrist actigraphy and expressed as a percentage. It was calculated as total sleep time divided by time in bed, multiplied by 100. Higher percentages indicate greater sleep efficiency. The device was worn overnight on the nondominant wrist. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. SE values from two consecutive nights under each condition were averaged for analysis.

    Over seven consecutive nights per participant, from baseline to completion of the interventions, sleep efficiency was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath).

Study Arms (2)

Sequence 1: Ankle-Level First

EXPERIMENTAL

Twenty participants received ankle-level warm-water footbaths, followed by routine care without footbaths, and then below-knee warm-water footbaths. Each condition lasted two days.

Other: Ankle-Level Warm-Water FootbathOther: Below-Knee Warm-Water Footbath

Sequence 2: Below-Knee First

EXPERIMENTAL

Twenty participants received below-knee warm-water footbaths, followed by routine care without footbaths, and then ankle-level warm-water footbaths. Each condition lasted two days.

Other: Ankle-Level Warm-Water FootbathOther: Below-Knee Warm-Water Footbath

Interventions

Participants immersed both feet in warm water at 42°C up to the ankle level for 15 minutes, approximately one hour before bedtime, on two consecutive days.

Sequence 1: Ankle-Level FirstSequence 2: Below-Knee First

Participants immersed both feet and lower legs in warm water at 42°C up to below the knees for 15 minutes, approximately one hour before bedtime, on two consecutive days.

Sequence 1: Ankle-Level FirstSequence 2: Below-Knee First

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 years or older.
  • Resided in a long-term care facility for at least 3 months.
  • Intact cognitive function, defined as a Short Portable Mental Status Questionnaire (SPMSQ) score ≥ 7 after adjustment for educational level.
  • Experienced sleep disturbances, defined as a Pittsburgh Sleep Quality Index (PSQI) score \> 5.

You may not qualify if:

  • Acute illness.
  • Psychiatric illness.
  • Lower extremity neuropathy.
  • Foot wounds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chiayi City Private Boren Elderly Care Center

Chiayi City, Chiayi City, 600, Taiwan

Location

Lantan Jiafu Nursing Home

Chiayi City, Chiayi City, 600, Taiwan

Location

Ruitai Nursing Home (Guangcai Branch)

Chiayi City, Chiayi City, 600, Taiwan

Location

Zhongxiao Nursing Home

Chiayi City, Chiayi City, 600, Taiwan

Location

Fumao Garden Nursing Home

Shuishang, Chiayi County, 608, Taiwan

Location

Madou Sin-Lau Nursing Home, the Presbyterian Church in Taiwan

Madou, Tainan City, 721, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Participants were assigned to one of two intervention sequences, with 20 participants in each sequence. Sequence 1: Ankle-level footbath, routine care, and below-knee footbath. Sequence 2: Below-knee footbath, routine care, and ankle-level footbath. Each condition lasted two days. Sleep outcomes were assessed under each condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 11, 2026

First Posted

October 23, 2026

Study Start

December 1, 2024

Primary Completion

January 27, 2025

Study Completion

January 27, 2025

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

There are no plans to share individual participant data (IPD) from this study.

Locations