Effect of physical activity on menopausal symptoms
| ISRCTN | ISRCTN54690027 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54690027 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/12/2008
- Registration date
- 17/12/2008
- Last edited
- 14/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Riitta Luoto
Scientific
Scientific
UKK Institute for Health Promotion
PO Box 30
Kaupinpuistonkatu 1
Tampere
33501
Finland
| Phone | +358 (0)3 282 9226 |
|---|---|
| riitta.luoto@uta.fi |
Study information
| Study design | Randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of physical activity on menopausal symptoms: a randomised clinical trial |
| Study objectives | 1. Increasing physical activity alleviates menopausal symptoms. 2. Physical activity increases quality of life of menopausal women through alleviating menopausal symptoms |
| Ethics approval(s) | Pirkanmaa Hospital District Ethics Committee, 02/12/2008, ref: R07199 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 11/01/2009 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 for the exercise group, 100 for comparison group |
| Key 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) |
| Key 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 |
| Date of first enrolment | 11/01/2009 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Finland
Study participating centre
UKK Institute for Health Promotion
Tampere
33501
Finland
33501
Finland
Sponsor information
The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)
Research organisation
Research organisation
PO Box 30
Kaupinpuistonkatu 1
Tampere
33501
Finland
| Phone | +358 (0)3 282 9226 |
|---|---|
| riitta.luoto@uta.fi | |
| Website | http://www.ukkinstituutti.fi |
"ROR" |
https://ror.org/05ydecq02 |
Funders
Funder type
Government
Academy of Finland (Finland)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
- Location
- Finland
Ministry of Health and Education (Finland)
No information available
Pirkanmaa Competitive Research Fund (Finland)
No information available
Yrjö Jansson Foundation (Finland)
No information available
Juho Vainio Foundation (Finland)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Juho Vainio Foundation, Reppy Institute
- Location
- Finland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No | |
| Results article | results | 01/09/2012 | Yes | No | |
| Results article | results | 11/09/2015 | Yes | No |
