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

JRCT ID: jRCTs061210062

Registered date:17/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: knee osteroarthritis
• Date of first enrollment: 04/08/2022
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Transdermal administration of Estradiol

Outcome(s)

Primary Outcome

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)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: <= 90age old
• Gender: Female

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: MITOMA TOMOHIRO