臨床研究等提出・公開システム

Home Oxygen Therapy on the Physical Activity of Daily Living Utilizing the Cloud-Based Home Care System (HOTPAL-study)

HOTPAL-study

Tanimura Kazuya

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara, JAPAN

tanimurak@naramed-u.ac.jp

Sakaguchi Kazuhiro

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara, JAPAN

+81-744-22-3051

k-sakaguchi@naramed-u.ac.jp

Recruiting

Oct. 10, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Patients with chronic respiratory failure meeting the criteria for home oxygen therapy or patients with chronic respiratory diseases who are considered to require home oxygen therapy by the attending phisician
2) Patients over 20 years old
3) Patients who have not been hospitalized for illnesses affecting their activities of daily living (ADL) within the last month

1) Patients with cancer (However, patients who have undergone curative treatment and are considered cured are eligible for inclusion)
2) Patients with comorbidities including severe cardiac, psychiatric, and neuromuscular diseases
3) Patients who spend almost the entire day in bed (Performance status is 3 or higher)
4) Inappropriate for the enrolment by the judgement of the principal investigator or the subinvestigators

Both

chronic respiratory failure (CRF)

Home oxygen therapy using cloud-based home healthcare system

Change in an equivalent of daily calorie consumption for a month before and 3 months after the initiation of home oxygen therapy (HOT)
*An equivalent of daily calorie consumption for a month
= Sum of equivalent of daily calorie consumption divided by the number of physically active days

1) Change over time in an equivalent of daily calorie consumption for each month including before initiation of HOT and after 1,2, and 3 month of HOT.
2) Change over time in a daily step counts and activity time for each month including before initiation of HOT and after 1,2, and 3 month of HOT.
3) Change over time in activity time according to an intensity of physical activity (1.1-1.9METs, 2.0-2.9METs, >= 3.0METs) before initiation of HOT and after 1,2, and 3 month of HOT.
4) Change in physical activity-related and depression-related indices 1 month before and 3 months after the initiation of HOT or at the time of discontinuation.
evaluation item: modified British Medical Research Council (mMRC), COPD assessment test (CAT), Life space assessment (LSA), Hospital Anxiety and Depression Scale (HADS)
5) Change over time in oxygen saturation (SpO2) and pulse rate before initiation of HOT and after 1,2, and 3 month of HOT.
*Evaluation will be in the morning when leaving the bed, during exertion (bathing, evacuation), and at bedtime

+81-744-29-8835

Aug. 22, 2023

Yes

This clinical study results, including Clinical Study Report (CSR), are provided FUKUDA LIFE TECH Co., Ltd. as contracted.

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