Frail ElderlyNCT07048015
Effect of Hot Water Foot Bath on Daily Living Activities, Insomnia and Fatigue Levels in Frail Geriatric Individuals
A study testing Hot Water Foot Bath in people with Frail Elderly, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Aim: A randomized controlled experimental study was conducted to determine the effect of hot water foot bath on daily living activities, sleep and fatigue levels in frail geriatric individuals. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Hot Water Foot Bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients aged 65 and over
- At least literate
- Able to communicate
- With an Edmonton Frailty Scale score of 7 and above were included in the study.
Who cannot join
- Patients diagnosed with a disease that may affect their mental status, such as dementia
- Those who have used other treatment methods such as massage or cupping therapy in the last month
- Those whose systolic blood pressure is lower than 100 mmHg
- Those diagnosed with malignancy and acute inflammatory rheumatic disease
- Those who have undergone any surgical operation in at least 6 months
- Those who have an orthopedic implant (in the foot or leg area)
Show all 16Show fewer
- Those who have paralysis and paralysis
- Those who have peripheral vascular disease
- Those who have ulcerative lesions in the legs
- Those who have a psychiatric disease diagnosis
- Those who are immobile
- Those who have fungal infections in their feet
- Those who are included in another study
- Those who have had a change in their treatment and nursing care process
- Those who have a diagnosis of neuropathy
- Patients who are allergic or sensitive to heat
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, Odunpazarı, 26040
About this study
Aim: A randomized controlled experimental study was conducted to determine the effect of hot water foot bath on daily living activities, sleep and fatigue levels in frail geriatric individuals.
Method: The study was conducted at Eskişehir Çifteler State Hospital internal medicine clinic between 15.10.2023 - 15.07.2024. 30 patients who met the sample selection criteria were randomized into two groups (study and control). Foot bath was applied to the study group every evening for 10 days. The study group was evaluated twice times on the 1st, 11th days, and the control group was evaluated twice on the 1st and 11th days in terms of frailty level, daily living activities, insomnia and fatigue severity.
- Conditions
- Frail Elderly
- Being tested
- Hot Water Foot Bath
- Keywords
- frail elderly, foot bath, daily living activities, insomnia, fatigue, pain
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot Water Foot BathOther
Hot Water Foot Bath:When the water temperature reached 40 ° C, the elderly person's feet were placed in the foot bath tub. The elderly person's feet were kept in the water for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Foot bath | Experimental | Foot bath: The foot bath was applied to the patients in the intervention group once a day for 20 minutes for 10 days. Receives: Other: Hot Water Foot Bath |
| control group | No intervention | No intervention was made to the patients in the control group other than the medical treatment and care protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of hot water foot bath on daily living activities, sleep and fatigue levels in frail geriatric individuals
Frail geriatric individuals were given hot water foot baths. The effects of this application on the individuals' daily living activities, sleep and fatigue levels were investigated. In the study, the individuals were administered the Edmoton Frailty Scale, the Katz Daily Living Activities Scale, the Insomnia Severity Index and the Fatigue Severity Scale via face-to-face interviews.
Measured: from registration until the end of the 40th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start15 Oct 2023
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first assessments (day 1) were made by the researcher using the Individual Identification Form, Katz Activities of Daily Living Scale, Insomnia Severity Index and Fatigue Severity Scale from patient files and face-to-face interviews with the patients. Foot bath was applied to the patients in the intervention group for 20 minutes once a day for 10 days. No intervention was made to the patients in the control group other than the medical treatment and care protocol. The second assessment was made on the 11th day by applying the , Katz Activities of Daily Living Scale, Insomnia Severity Index and Fatigue Severity Scale to the patients in the study and control groups.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munevver Kiyak, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048015
- Sponsor's protocol ID
- KGBSABGUYE
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malarvizhi, K. R. (2019). A study to assess the effectiveness of hot water foot bath therapy on quality of sleep among elderly staying in selected old age home at Villupuram District, Tamilnadu. International Journal of Health Sciences and Research, 4(4), 83-88.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hot Water Foot Bath on Daily Living Activities, Insomnia and Fatigue Levels in Frail Geriatric Individuals
- ClinicalTrials.gov ID
- NCT07048015
- Acronym / sponsor ID
- KGBSABGUYE
- Conditions
- Frail Elderly
- Keywords
- frail elderly, foot bath, daily living activities, insomnia, fatigue, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: A randomized controlled experimental study was conducted to determine the effect of hot water foot bath on daily living activities, sleep and fatigue levels in frail geriatric individuals.
Method: The study was conducted at Eskişehir Çifteler State Hospital internal medicine clinic between 15.10.2023 - 15.07.2024. 30 patients who met the sample selection criteria were randomized into two groups (study and control). Foot bath was applied to the study group every evening for 10 days. The study group was evaluated twice times on the 1st, 11th days, and the control group was evaluated twice on the 1st and 11th days in terms of frailty level, daily living activities, insomnia and fatigue severity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first assessments (day 1) were made by the researcher using the Individual Identification Form, Katz Activities of Daily Living Scale, Insomnia Severity Index and Fatigue Severity Scale from patient files and face-to-face interviews with the patients. Foot bath was applied to the patients in the intervention group for 20 minutes once a day for 10 days. No intervention was made to the patients in the control group other than the medical treatment and care protocol. The second assessment was made on the 11th day by applying the , Katz Activities of Daily Living Scale, Insomnia Severity Index and Fatigue Severity Scale to the patients in the study and control groups.
| Arm | Type | Receives |
|---|---|---|
| Foot bath | Experimental | Other: Hot Water Foot BathFoot bath: The foot bath was applied to the patients in the intervention group once a day for 20 minutes for 10 days. |
| control group | No intervention | –No intervention was made to the patients in the control group other than the medical treatment and care protocol. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients aged 65 and over
- At least literate
- Able to communicate
- With an Edmonton Frailty Scale score of 7 and above were included in the study.
Key exclusion criteria (16 listed)
- Patients diagnosed with a disease that may affect their mental status, such as dementia
- Those who have used other treatment methods such as massage or cupping therapy in the last month
- Those whose systolic blood pressure is lower than 100 mmHg
- Those diagnosed with malignancy and acute inflammatory rheumatic disease
- Those who have undergone any surgical operation in at least 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot Water Foot BathHot Water Foot Bath:When the water temperature reached 40 ° C, the elderly person's feet were placed in the foot bath tub. The elderly person's feet were kept in the water for 20 minutes. | Other | Foot bath |
Primary outcome
Effect of hot water foot bath on daily living activities, sleep and fatigue levels in frail geriatric individuals
Time frame: from registration until the end of the 40th day
Frail geriatric individuals were given hot water foot baths. The effects of this application on the individuals' daily living activities, sleep and fatigue levels were investigated. In the study, the individuals were administered the Edmoton Frailty Scale, the Katz Daily Living Activities Scale, the Insomnia Severity Index and the Fatigue Severity Scale via face-to-face interviews.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- BackgroundMalarvizhi, K. R. (2019). A study to assess the effectiveness of hot water foot bath therapy on quality of sleep among elderly staying in selected old age home at Villupuram District, Tamilnadu. International Journal of Health Sciences and Research, 4(4), 83-88.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot Water Foot Bath in people with Frail Elderly, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of hot water foot bath on daily living activities, sleep and fatigue levels in frail geriatric individuals (time frame: from registration until the end of the 40th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07048015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.