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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06030388
Other study ID # START2022-05030-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 12, 2023
Est. completion date December 2032

Study information

Verified date September 2023
Source Linkoeping University
Contact Anna-Clara Spetz Holm, Ass prof, MD
Phone +46101033130
Email anna-clara.spetz.holm@liu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this randomised controlled trial is to investigate the effects of and compare two modes of physical exercise (strength training and high-intensity aerobic exercise) to unchanged physical activity on vasomotor symptoms (hot flushes) in postmenopausal women. The main question it aims to answer is the effect of 15 weeks of strength training vs high intensity aerobic training vs unchanged physical activity on frequency and severity of hot flushes. Participants will be randomised to: 1. strength training 2. high-intensity aerobic training 3. untreated control group. Researchers will compare strength training, high-intensity aerobic training and untreated control group to see if training can reduce hot flushes.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Strength training
Both interventions (strength training and high intensity aerobic training) will be introduced with a 3-week adaptation period with lower loads (strength training) or intensity (aerobic training) followed by a 12-week period on the intended load/intensity. All participants in the intervention groups will be recommended to exercise three times per week (one hour per session) and in addition be active with everyday low-intensity physical activity. A structured and detailed training diary will be used in both groups to register frequency of each training session, as well as everyday physical activity. For the strength training, load and dose will also be registered for each training session.
High-intensity aerobic training
Both interventions (strength training and high intensity aerobic training) will be introduced with a 3-week adaptation period with lower loads (strength training) or intensity (aerobic training) followed by a 12-week period on the intended load/intensity. All participants in the intervention groups will be recommended to exercise three times per week (one hour per session) and in addition be active with everyday low-intensity physical activity. A structured and detailed training diary will be used in both groups to register frequency of each training session, as well as everyday physical activity. For the strength training, load and dose will also be registered for each training session.

Locations

Country Name City State
Sweden Region Kalmar Län Kalmar
Sweden Region Östergötland Linköping

Sponsors (3)

Lead Sponsor Collaborator
Linkoeping University Länssjukhuset i Kalmar län, Region Östergötland

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Berin E, Hammar M, Lindblom H, Lindh-Astrand L, Ruber M, Spetz Holm AC. Resistance training for hot flushes in postmenopausal women: A randomised controlled trial. Maturitas. 2019 Aug;126:55-60. doi: 10.1016/j.maturitas.2019.05.005. Epub 2019 May 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of moderate and severe hot flushes Frequency of hot flushes per 24 h daily recorded in hot flush diary from baseline throughout 15 weeks of intervention. baseline to 15 weeks
Secondary Frequency of moderate and severe hot flushes Frequency of hot flushes per 24 h daily recorded in hot flush diary 2 weeks at baseline and 2 weeks at each of the time points. baseline to 6 months, 1, 2 and 5 years
Secondary Severity of hot flushes Severity of hot flushes per 24 hours recorded in hot flush diary from baseline throughout 15 weeks of intervention and two weeks during follow-up. baseline to 15 weeks, 6 months, 1, 2 and 5 years
Secondary Generic health-related quality of life Short-form 36, 36 questions in 8 scales. Scores for each domain range from 0-100, and a high score represents a higher health-related quality of life. baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Secondary Women specific health-related quality of life Women's health questionnaire nine sub-scales with four-point scales (yes definitely, yes sometimes, not not much, no not at all) that are reduced to binary options (0/1). The subscale items are summated and divided by the number of items in each subscale.A higher score represents worse outcome. baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Secondary Physical activity levels International Physical Activity Questionnaire short form, the participant describes the amount of time (minutes and hours) that is spent on different physical activities each week, the more time, the better, except for the question about the amount of time spent in sitting. baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Secondary Sleep quality Pittsburgh sleep quality index, 7 domains. For the total instrument, the lower score, the better, from 0 (best) to 21 (worst). baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Secondary Diet Bespoke questionnaire, primarily to control for changes during the intervention period. Registration of amounts or portions. Results are presented question by question descriptively. baseline to 15 weeks, 6 months, 1, 2 and 5 years
Secondary Accomplished physical activity Bespoke training diary baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Secondary Bioimpedance Fat mass (%) and fat-free (muscle) mass (%) baseline to 15 weeks
Secondary Weight kilogram (kg) baseline to 15 weeks
Secondary Lenght meters (m) baseline to 15 weeks
Secondary Body mass index kilograms/meters2 (kg/m2) baseline to 15 weeks
Secondary Waist circumference millimeters (mm) baseline to 15 weeks
Secondary Systolic and diastolic blood pressure Unit millimetre of mercury (mmHg) baseline to 15 weeks
Secondary Hematologic and ironstatus changes Hemoglobin full body count, Transferrin(gram/Litre), and Ferritin (microgram/Litre) baseline to 15 weeks, and 1 year
Secondary Changes in blood-lipids apolipoprotein A1, apolipoprotein B (gram/Litre) and total cholesterol, low-density lipoprotein, high-density lipoprotein (mmol/L) and leptin (ng/mL) baseline to 15 weeks, and 1 year
Secondary Changes in sex hormones and gonadotrophins Estradiol (pmol/Litre), Sex hormone bindning globulin, Testosterone (nmol/Litre), follicle-stimulating hormone, luteinizing hormone (IE/Litre) baseline to 15 weeks, and 1 year
Secondary Changes in glucose profile HbA1c (mmol/Litre) and fasting blood glucose (mmol/L) baseline to 15 weeks, and 1 year
Secondary Changes in inflammatory biomarkers high-sensitive C-reactive Protein (microgram/Litre), Brain-derived neutrophic factor, Matrix metalloproteinase-2 and -9 (ng/mL), Interleukin -4, -6, -7, -8, 10, -15, tumour necrosis factor, monocyte chemoattractant protein-1 (pg/mL) baseline to 15 weeks, and 1 year
Secondary Changes in the lenght of telomeres in white blood cells Telomeres (kilobase) pair baseline to 15 weeks, and 1 year
Secondary Change in exercise capacity Change in exercise capacity is primarily used as a measure of adherence and obtained through cardiopulmonary exercise testing assessing maximum oxygen uptake milliliter/kilogram/minute (ml/kg/minute) and analysed according to local clinical routines. baseline to 15 weeks
Secondary Experiences of the interventions, facilitators and barriers Bespoke questionnaire, only for intervention groups. Results will be presented descriptively question by question. baseline to 15 weeks
Secondary Adherence to the interventions Assessed through bespoke training diary where each training session is registered and the total number of training sessions as well as training sessions/week will be calculated. baseline to 15 weeks
Secondary Muscle strength For strength training group only, measured using 8 repetition-maximum tests. baseline to 15 weeks
Secondary Adverse events Adverse events of taking part in the study baseline to 15 weeks
See also
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Completed NCT05419908 - Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes Phase 2
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Active, not recruiting NCT05086705 - EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer N/A
Completed NCT05099159 - A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) Phase 3
Completed NCT01140646 - Evaluation of SAMe for Hot Flashes Phase 2
Completed NCT00956813 - Flaxseed in Treating Postmenopausal Women With Hot Flashes Who Have a History of Breast Cancer or Other Cancer or Who Do Not Wish to Take Estrogen Therapy Phase 3