Health Effects of Resistance Training on Postmenopausal Women

Ostergotland County Council, Sweden

Status: Completed

Conditions: Menopause; Hot Flashes

Treatments: Other: Resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT01987778

20131105/Styrka

Details and patient eligibility

About

Today's women will live more than a third of their lives after menopause, i.e. with a changed hormonal and metabolic state. Vasomotor symptoms like hot flushes and sweating are reported by about 75% of all women around menopause and may impair well-being, mental state, daily activities and night sleep. Vasomotor symptoms are less prevalent in women who participate in regular physical exercise. It is, however, still uncertain if physical exercise reduces vasomotor symptoms.

The purpose of this randomized controlled study is to establish possible beneficial health effects from 15 weeks of supervised resistance training (RT) on postmenopausal women. End-points include effects from RT in postmenopausal women on

1. clinical outcomes (number and severity of vasomotor symptoms, Health-Related quality of Life (HRQoL), Body Mass Index (BMI), abdominal height, muscle strength and mass, browning of fat),
2. diagnostic variables (production of myokines as irisin, immunological markers) and
3. genetic variables (length of telomeres).

The control group will be offered resistance training after the intervention period.

Full description

The first phase is planned as a pilot-study including 20 women participating for 15 weeks. Thereafter an evaluation of the sample size and the study methodology will be made.

Enrollment: 65 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women who had at least 28 moderate to severe hot flashes per week during a screening period of two weeks.(Postmenopausal, i.e. had their last menstrual bleeding at least 12 months ago or have increased gonadotrophic hormones showing they are postmenopausal.)
• At lest 45 years of age
• Good physical health and physical ability to take part in organized resistance training or other training at least three times per week.
• Ability to speak and read Swedish
• Freely informed consent for participation

Exclusion criteria

• Physically active more than 75 minutes of intense exercise per week or more than 150 minutes of low intensity activities
• Hb <110 g/l
• Blood pressure >160 systolic and/or >100 mmHg diastolic pressure
• Ongoing usage or use during the last two months of hormone therapy aimed for hot flashes
• Treatment with psychopharmacological drugs (e.g SSRI or SNRI) or other treatment with a possible effect on menopausal symptoms
• Uninvestigated or unstable disease that could affect presence of flushes (e.g thyroid disease)
• Other medical condition that is judged inappropriate to combine with physical activity or participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Resistance training

Experimental group

Description:

The resistance training will be supervised and individualized by an experienced physiotherapist. First the relative load will be lighter during three weeks, thereafter the intensity and load will be increased over another 12 weeks.

Treatment:

Other: Resistance training

Control group

No Intervention group

Description:

No intervention for 15 weeks but the same registrations, diaries and forms as the intervention group. The control group will however be omitted from muscle strength testing.