Condition category
Urological and Genital Diseases
Date applied
10/12/2008
Date assigned
17/12/2008
Last edited
14/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Riitta Luoto

ORCID ID

Contact details

UKK Institute for Health Promotion
PO Box 30
Kaupinpuistonkatu 1
Tampere
33501
Finland
+358 (0)3 282 9226
riitta.luoto@uta.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of physical activity on menopausal symptoms: a randomised clinical trial

Acronym

Study hypothesis

1. Increasing physical activity alleviates menopausal symptoms.
2. Physical activity increases quality of life of menopausal women through alleviating menopausal symptoms

Ethics approval

Pirkanmaa Hospital District Ethics Committee, 02/12/2008, ref: R07199

Study design

Randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Menopausal symptoms

Intervention

Intervention:
Moderate intensity aerobic training for 6 months, 4 times per week walking (or Nordic walking) for 50 minutes at 60% of maximal oxygen uptake (VO2max).

Control:
Continue earlier habits.

Duration of follow-up is 6 months for both arms.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Vasomotor symptoms as measured with validated scale (Women's Health Questionnaire [WHQ]). WHQ enables assessment of depression, anxiety, sleep problems, somatic symptoms with optional subscales for menstrual problems and sexual difficulties.

Timepoint of the measurements is 0 and 6 months; baseline and end of the trial in both primary and secondary outcomes.

Secondary outcome measures

1. Other menopausal symptoms, such as urogenital and cognitive symptoms
2. Physical activity and health-related physical fitness (estimated maximal oxygen consumption, muscle strength)
3. Components of metabolic syndrome (weight, waist circumference, and fasting plasma high density lipoprotein [HDL] cholesterol, triglycerides, glucose and insulin)
4. Workability

Timepoint of the measurements is 0 and 6 months; baseline and end of the trial in both primary and secondary outcomes.

Overall trial start date

11/01/2009

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Symptomatic (severe or very severe or moderate daily hot flushes) women
2. Aged 40 - 60 years
3. No current use of oestrogen hormone treatment (HT, without or with progesterone) or any other treatment or withdrawal (wash-out period 3 months)
4. Sedentary (physical exercise less than twice weekly)
5. Six to 36 months from last menstruation (peri-menopausal)
6. Follicle stimulating hormone (FSH) elevated (at least 30 IU/l)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100 for the exercise group, 100 for comparison group

Participant exclusion criteria

1. Physically active women (greater than two times/week, at least 30 minutes)
2. Body mass index (BMI) greater than 35 kg/m^2
3. Coronary heart disease, orthopaedic or other diseases preventing from exercising

Recruitment start date

11/01/2009

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Finland

Trial participating centre

UKK Institute for Health Promotion
Tampere
33501
Finland

Sponsor information

Organisation

The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)

Sponsor details

PO Box 30
Kaupinpuistonkatu 1
Tampere
33501
Finland
+358 (0)3 282 9226
riitta.luoto@uta.fi

Sponsor type

Research organisation

Website

http://www.ukkinstituutti.fi

Funders

Funder type

Government

Funder name

Academy of Finland (Finland)

Alternative name(s)

Academy of Finland

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Finland

Funder name

Ministry of Health and Education (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pirkanmaa Competitive Research Fund (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Yrjö Jansson Foundation (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Juho Vainio Foundation (Finland)

Alternative name(s)

Juho Vainio Foundation, Reppy Institute

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Finland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22673453
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21639722
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26362664

Publication citations

  1. Results

    Mansikkamäki K, Raitanen J, Nygård CH, Heinonen R, Mikkola T, EijaTomás, Luoto R, Sleep quality and aerobic training among menopausal women--a randomized controlled trial., Maturitas, 2012, 72, 4, 339-345, doi: 10.1016/j.maturitas.2012.05.003.

  2. Luoto R, Moilanen J, Heinonen R, Mikkola T, Raitanen J, Tomas E, Ojala K, Mansikkamäki K, Nygård CH, Effect of aerobic training on hot flushes and quality of life--a randomized controlled trial., Ann. Med., 2012, 44, 6, 616-626, doi: 10.3109/07853890.2011.583674.

  3. Results

    Mansikkamäki K, Raitanen J, Nygård CH, Tomás E, Rutanen R, Luoto R, Long-term effect of physical activity on health-related quality of life among menopausal women: a 4-year follow-up study to a randomised controlled trial, BMJ Open, 2015, 5, 9, e008232, doi: 10.1136/bmjopen-2015-008232.

Additional files

Editorial Notes