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Dec. 17, 2021

Nov. 17, 2022

jRCTs061210062

A randomized, placebo-controlled, double-blinded clinical trial of the Estrogen replacement effect on Physical Performance to muscle resistance exercise for elderly with Osteoarthritis of Knee joint. (The EPOK Trial)

Clinical trial of the Estrogen replacement effect on Physical Performance to muscle resistance exercise for elderly with Osteoarthritis of Knee joint. (The EPOK Trial)

MITOMA TOMOHIRO

OKAYAMA University Hospital

2-5-1 Shikata-cho kita-ku, Okayama

+81-86-235-7320

tomohiro.mitoma@gmail.com

MITOMA TOMOHIRO

OKAYAMA University Hospital

2-5-1 Shikata-cho kita-ku, Okayama

+81-86-235-7320

tomohiro.mitoma@gmail.com

Recruiting

Dec. 17, 2021

Aug. 04, 2022
80

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

For those that meet all the following criteria.
(1) The person that a document agreement was
provided after enough understanding and have been received enough explanation on participating of this study.
(2) A person who is 65 years of age or older when
obtaining consent.
(3) A person who has osteoarthritis with knee pain at least 3 months
(4) A person who can walk themselves without any help.

For those meet one of the following exclusion criteria.
(1) Those who are diagnosed following disease or condition having difficult to perform exercise.
Cardiovascular disease, Cerebral palsy, Home oxygen therapy, Mental illness
(2) History of lower limb bone fracture within 2 years,upper limb bone fracture within 6 months.
(3) those who are bedridden condition for more than 1 week within 2 months, or bedridden condition for more than 2 weeks within 6 months
(4) Those who have difficulty ingesting
(5) History of Endometrial cancer, Ovarian cancer, Peritoreal cancer, Cervical cancer within 5 years.
(6) History of Breast cancer within 5 years.
(7) Those who have severe liver function disorder

65age 0month 0week old over
90age 0month 0week old under

Female

knee osteroarthritis

Transdermal administration of Estradiol

knee osteoarthritis

Estrogen replacement therapy

D020370

D015914

Compare the degree of lower limb physical performance.
The most important evaluation factor is Chair stand test-30sec ( The arms are to be crossed at the wrists and held close to the chest. From the sitting position, the subject stands completely up, then completely back down, and this is repeated for 30 seconds.)
The measurement has to be done once before intervention and twice after intervention(3month, 12month after)

1) Knee pain score: Visual Analogue
2) Muscle Strength:
3) Muscle Mass: Total Lean Mass, Skeletal Muscle Index
4) Physical Performance: Gait speed,Timed up and go
5) Blood Sample
6) Quality of Life: Short Form Health Survey -12

Okayama University Certified Review Board
2-5-1 shikata-cho, Kita-ku,, Okayama

+81-86-235-7133

ouh-crrb@adm.okayama-u.ac.jp
Approval

Nov. 24, 2021

none

History of Changes

No Publication date
3 Nov. 17, 2022 (this page) Changes
2 June. 16, 2022 Detail Changes
1 Dec. 17, 2021 Detail