Clinical trial NCT01987778: Health Effects of Resistance Training on Postmenopausal Women
Official title: Health Effects of Resistance Training on Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Menopause
Keywords: Hot flashes
Menopause
HRQoL
Resistance training
Physical activity
Adipose tissue
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2013-11-19
Enrollment: 65
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in frequency of hot flushes per 24 h
timeFrame: Baseline to 15 weeks of intervention/control group
Secondary outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
measure: Muscle strength
timeFrame: Baseline to 15 weeks of intervention
measure: Level of physical activity
timeFrame: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
measure: Concentrations of adipo-myokines/inflammatory biomarkers
timeFrame: Baseline to 15 weeks of intervention/control group
measure: Length of telomeres
timeFrame: Baseline to 15 weeks of intervention/control group
measure: Volume of white and brown adipose tissue and muscle volume
timeFrame: Baseline to 15 weeks of intervention/control group
measure: Body mass index and abdominal height
timeFrame: Baseline to 15 weeks of intervention/control group
measure: Blood pressure
timeFrame: Baseline to 15 weeks of intervention/control group
measure: Severity of hot flushes
timeFrame: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: County Council of Östergötland, Kvinnokliniken
Study officials:
affiliation: Linkoeping University
name: Mats L Hammar, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lindh-Astrand L, Nedstrand E, Wyon Y, Hammar M. Vasomotor symptoms and quality of life in previously sedentary postmenopausal women randomised to physical activity or estrogen therapy. Maturitas. 2004 Jun 15;48(2):97-105. doi: 10.1016/S0378-5122(03)00187-7.
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citation: Berin E, Spetz Holm AC, Hammar M, Lindh-Astrand L, Bertero C. Postmenopausal women's experiences of a resistance training intervention against vasomotor symptoms: a qualitative study. BMC Womens Health. 2022 Jul 30;22(1):320. doi: 10.1186/s12905-022-01900-0.