Effect of Aerobic Exercises With Selected Phytoestrogens on Hot Flushes in Menopausal Women

Cairo University (CU)

Status: Unknown

Conditions: Hot Flashes

Treatments: Behavioral: Aerobic excercise; Dietary Supplement: soy products

Study type: Interventional

Funder types: Other

Identifiers

NCT03434171

26

Details and patient eligibility

About

50 menopausal women with the diagnosis of hot flushes were randomized to 1 of 2 groups

Group (A):

It consists of 25 women who practiced treadmill exercise program for 30 minutes at 60% to 70% of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks.

Group (B):

It consists of 25 women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only.

Full description

50 menopausal women with the diagnosis of hot flushes were randomized to 1 of 2 groups

Group (A):

It consists of 25 women who practiced treadmill exercise program for 30 minutes at 60% to 70% of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks.

Group (B):

It consists of 25 women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only.

Enrollment: 50 estimated patients

Sex: Female

Ages: 47 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• menopausal women minimum 2 years after menopause Patients were required to have at least moderate hot flashes at time of randomization, having a score ≥ 40 in Hot Flash-Related Daily Interference Scale (HFRDIS)

Exclusion criteria

• women with BMI > 30kg/m2 ingestion of any psychotropic and antidepressant medications, any Selective Estrogen Receptor Modulator medications (e.g., tamoxifen and raloxifen), any Aaromatase inhibitor medications (e.g., anastrozole, letrozole, and exemestane), leuprolide acetate, clonidine, gabapentin, pregabalin, amino acid supplements, over the counter (OTC) medications that reduced hot flashes during the last 4 weeks, ingestion of estrogen and progesterone based medications, history of suicidal thoughts, substance or alcohol dependence (with the exception of nicotine dependence) during the last 3 months and Electroconvulsive therapy (ECT) during the last 2 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Aerobic excercise

Active Comparator group

Description:

women who practiced treadmill exercise program for 30 minutes at 60% to 70% of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks

Treatment:

Dietary Supplement: soy products

Behavioral: Aerobic excercise

Dietary modfications

Active Comparator group

Description:

women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only

Treatment:

Dietary Supplement: soy products