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Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women (START)

Primary Purpose

Postmenopausal Symptoms, Hot Flashes

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Strength training
High-intensity aerobic training
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Symptoms focused on measuring aerobic training, strength training

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postmenopausal women (one of: ≥ 12 months since last menstruation; amenorrhea due to intrauterine device or hysterectomy and Follicle Stimulating Hormone (FSH) >30 mIU/ml; bilateral oophorectomy; induced menopause due to chemotherapy or radiation and ≥2 years amenorrhea); ≥ 28 moderate to severe hot flushes per week during a 2-week screening period, registered through a daily VMS diary; Age ≥45 years; Physical ability to participate in strength training or high intensity aerobic exercise for 60 minutes, 3 times/week during 15 weeks; Understand Swedish orally and in writing Exclusion Criteria: Regular physical activity >30 minutes per week of vigorous intensity or ≥150 minutes of moderate intensity or combined activities representing maximum 150 minutes of moderate intensity; Use of systemic menopausal hormone therapy the last 2 months; Use of natural preparations such as herbal preparations for VMS, or other medications for VMS the last 2 months; Capillary hemoglobin <110 g/l; Blood pressure >160 mmHg systolic or >100 mmHg diastolic; Unstable medical condition with a potential to affect VMS (like unregulated thyroid disease); Medical condition that by a physician is judged not appropriate (because of potential to affect VMS or risk of injury with vigorous exercise)

Sites / Locations

  • Region Kalmar LänRecruiting
  • Region ÖstergötlandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Strength training

High-intensity aerobic training

Control group

Arm Description

Standardised programme with the following exercises: chest press, leg press, row, leg curl, latissimus dorsi pull down and leg extension in seated resistance machines. Training will be preceded by 7-10 minutes of warm-up and followed by two body-weight exercises for the abdominal and back muscles for two sets as many repetitions as possible, and thereafter cool down and stretches. The set-up of each machine will be recorded in the training diary. Weeks 1-3 will include two sets of training with 15-20 repetition-maximum (RM) and weeks 4-15 two sets with 8-12 RM. Throughout the intervention, loads will be adjusted to achieve muscle fatigue and approach training to failure during each set with the intent to maximize beta-endorphin release.

Participants will be recommended to attend spinning classes three times per week. During their first visit to the training venue, they will meet a sports physiotherapist or personal trainer to be introduced to the spinning bike intervention. The intended intensity is ≥ 14 on the Borg rating of perceived exertion scale, equivalent to high intensity training (>70% of VO2max) with the aim of attaining sufficient stimulus for beta-endorphin release. During weeks 1-3 participants will attend spinning classes for beginners with lower intensity and predominantly seated cycling. They will progress to higher intensity classes with greater variation between seated and standing cycling during week 4-15.

The control group will be recommended to carry on physical activity as usual and not to change their training or dietary habits during the 15-week study period. The control group will be contacted every fourth weeks by a research nurse to follow up on their general well-being and any questions they might have about menopause. After the study period they will be offered individual advise about training from a physiotherapist or personal trainer.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Sleep quality
Pittsburgh sleep quality index, 7 domains. For the total instrument, the lower score, the better, from 0 (best) to 21 (worst).
Diet
Bespoke questionnaire, primarily to control for changes during the intervention period. Registration of amounts or portions. Results are presented question by question descriptively.
Accomplished physical activity
Bespoke training diary
Bioimpedance
Fat mass (%) and fat-free (muscle) mass (%)
Weight
kilogram (kg)
Lenght
meters (m)
Body mass index
kilograms/meters2 (kg/m2)
Waist circumference
millimeters (mm)
Systolic and diastolic blood pressure
Unit millimetre of mercury (mmHg)
Hematologic and ironstatus changes
Hemoglobin full body count, Transferrin(gram/Litre), and Ferritin (microgram/Litre)
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)
Changes in sex hormones and gonadotrophins
Estradiol (pmol/Litre), Sex hormone bindning globulin, Testosterone (nmol/Litre), follicle-stimulating hormone, luteinizing hormone (IE/Litre)
Changes in glucose profile
HbA1c (mmol/Litre) and fasting blood glucose (mmol/L)
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)
Changes in the lenght of telomeres in white blood cells
Telomeres (kilobase) pair
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.
Experiences of the interventions, facilitators and barriers
Bespoke questionnaire, only for intervention groups. Results will be presented descriptively question by question.
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.
Muscle strength
For strength training group only, measured using 8 repetition-maximum tests.
Adverse events
Adverse events of taking part in the study

Full Information

First Posted
June 15, 2023
Last Updated
September 21, 2023
Sponsor
Linkoeping University
Collaborators
Region Östergötland, Länssjukhuset i Kalmar län
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1. Study Identification

Unique Protocol Identification Number
NCT06030388
Brief Title
Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women
Acronym
START
Official Title
STrength and AeRobic Training Against Vasomotor Symptoms (START) in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
December 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Region Östergötland, Länssjukhuset i Kalmar län

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: strength training high-intensity aerobic training untreated control group. Researchers will compare strength training, high-intensity aerobic training and untreated control group to see if training can reduce hot flushes.
Detailed Description
The overall aim is to investigate the efficacy of and compare two modes of physical exercise (strength training and high-intensity aerobic exercise) to unchanged physical activity on vasomotor symptoms (VMS), as well as secondary outcomes such as health-related quality of life, sleep quality, physical activity levels, clinical outcomes, biomarkers, perceptions of and adherence to the interventions. In a longer perspective, the goal is to find evidence-based treatment options for VMS in postmenopausal women that are safe and effective, and have positive effects on health and quality of life after menopause. Our hypothesis is that strength training and high-intensity aerobic exercise will reduce VMS in postmenopausal women and improve quality of life as well as clinical outcomes more than in a control group with unchanged physical activity. We also hypothesize that strength training and high-intensity aerobic training will have the same effect on the primary outcome (change in VMS) and that most of the changes in secondary outcomes will be superior in the high-intensity aerobic training group compared to the strength training group. This is an open, two-centre, parallel, randomized controlled study performed according to the SPIRIT and CONSORT statements Recruitment will take place by advertising on social media, in local newspapers and in the Women's clinics and primary care centers in Linköping and Kalmar. Women who respond to the advertisements will be contacted by a member of the research group or research nurse to receive information about the study and screen for inclusion and exclusion criteria. Women who are possibly eligible will be invited to a screening visit for further information and informed consent. At the visit, inclusion and exclusion criteria will be checked by a physician, and a clinical examination will be performed. Eligible participants will receive a VMS screening diary and invited to a second visit 2-3 weeks later where inclusion and randomization will be performed if the VMS inclusion criteria are fulfilled. Randomization An allocation sequence using a computerized random number generator will be prepared by a statistician not involved in recruitment. Opaque sealed and sequentially numbered envelopes with group allocation will be prepared and opened in the presence of the participant upon inclusion and randomization. Power analysis: A sample size calculation was made based on the results of our previous study on strength training for VMS (Berin et al 2019) and showed that to detect a 50% difference in moderate and severe hot flushes with 80% power and expected dropout rate of 20% 40 participants in total would be needed. For this three-armed set-up we estimate that 20 participants in each group will be needed, i.e. 60 in total. To also achieve sufficient power for some of the secondary outcomes the intended sample size is increased to 30 per group, 90 in total. Data analysis: The primary analysis will be performed according to the intention-to-treat principle, including all participants who provided more than baseline data for the primary outcome. For quantitative interval data mixed design ANOVAs will be used to analyze the effect over time between and within groups. For the between-group comparisons effect sizes will be calculated. For ordinal data, such as the questionnaires, Kruskal-Wallis and Friedman test will be used for statistical analysis of the effect. Participants who complete two or more training sessions per week will be considered adherent with their assigned intervention and included in a per-protocol analysis. Detailed description of adherence, such as the fidelity with the training interventions, will be presented descriptively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Symptoms, Hot Flashes
Keywords
aerobic training, strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three-armed randomised trial where participants are randomised to 1) strength training, 2) high-intensity aerobic training or 3) untreated control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strength training
Arm Type
Active Comparator
Arm Description
Standardised programme with the following exercises: chest press, leg press, row, leg curl, latissimus dorsi pull down and leg extension in seated resistance machines. Training will be preceded by 7-10 minutes of warm-up and followed by two body-weight exercises for the abdominal and back muscles for two sets as many repetitions as possible, and thereafter cool down and stretches. The set-up of each machine will be recorded in the training diary. Weeks 1-3 will include two sets of training with 15-20 repetition-maximum (RM) and weeks 4-15 two sets with 8-12 RM. Throughout the intervention, loads will be adjusted to achieve muscle fatigue and approach training to failure during each set with the intent to maximize beta-endorphin release.
Arm Title
High-intensity aerobic training
Arm Type
Active Comparator
Arm Description
Participants will be recommended to attend spinning classes three times per week. During their first visit to the training venue, they will meet a sports physiotherapist or personal trainer to be introduced to the spinning bike intervention. The intended intensity is ≥ 14 on the Borg rating of perceived exertion scale, equivalent to high intensity training (>70% of VO2max) with the aim of attaining sufficient stimulus for beta-endorphin release. During weeks 1-3 participants will attend spinning classes for beginners with lower intensity and predominantly seated cycling. They will progress to higher intensity classes with greater variation between seated and standing cycling during week 4-15.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will be recommended to carry on physical activity as usual and not to change their training or dietary habits during the 15-week study period. The control group will be contacted every fourth weeks by a research nurse to follow up on their general well-being and any questions they might have about menopause. After the study period they will be offered individual advise about training from a physiotherapist or personal trainer.
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High-intensity aerobic training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of moderate and severe hot flushes
Description
Frequency of hot flushes per 24 h daily recorded in hot flush diary from baseline throughout 15 weeks of intervention.
Time Frame
baseline to 15 weeks
Secondary Outcome Measure Information:
Title
Frequency of moderate and severe hot flushes
Description
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.
Time Frame
baseline to 6 months, 1, 2 and 5 years
Title
Severity of hot flushes
Description
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.
Time Frame
baseline to 15 weeks, 6 months, 1, 2 and 5 years
Title
Generic health-related quality of life
Description
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.
Time Frame
baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Title
Women specific health-related quality of life
Description
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.
Time Frame
baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Title
Physical activity levels
Description
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.
Time Frame
baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Title
Sleep quality
Description
Pittsburgh sleep quality index, 7 domains. For the total instrument, the lower score, the better, from 0 (best) to 21 (worst).
Time Frame
baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Title
Diet
Description
Bespoke questionnaire, primarily to control for changes during the intervention period. Registration of amounts or portions. Results are presented question by question descriptively.
Time Frame
baseline to 15 weeks, 6 months, 1, 2 and 5 years
Title
Accomplished physical activity
Description
Bespoke training diary
Time Frame
baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Title
Bioimpedance
Description
Fat mass (%) and fat-free (muscle) mass (%)
Time Frame
baseline to 15 weeks
Title
Weight
Description
kilogram (kg)
Time Frame
baseline to 15 weeks
Title
Lenght
Description
meters (m)
Time Frame
baseline to 15 weeks
Title
Body mass index
Description
kilograms/meters2 (kg/m2)
Time Frame
baseline to 15 weeks
Title
Waist circumference
Description
millimeters (mm)
Time Frame
baseline to 15 weeks
Title
Systolic and diastolic blood pressure
Description
Unit millimetre of mercury (mmHg)
Time Frame
baseline to 15 weeks
Title
Hematologic and ironstatus changes
Description
Hemoglobin full body count, Transferrin(gram/Litre), and Ferritin (microgram/Litre)
Time Frame
baseline to 15 weeks, and 1 year
Title
Changes in blood-lipids
Description
apolipoprotein A1, apolipoprotein B (gram/Litre) and total cholesterol, low-density lipoprotein, high-density lipoprotein (mmol/L) and leptin (ng/mL)
Time Frame
baseline to 15 weeks, and 1 year
Title
Changes in sex hormones and gonadotrophins
Description
Estradiol (pmol/Litre), Sex hormone bindning globulin, Testosterone (nmol/Litre), follicle-stimulating hormone, luteinizing hormone (IE/Litre)
Time Frame
baseline to 15 weeks, and 1 year
Title
Changes in glucose profile
Description
HbA1c (mmol/Litre) and fasting blood glucose (mmol/L)
Time Frame
baseline to 15 weeks, and 1 year
Title
Changes in inflammatory biomarkers
Description
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)
Time Frame
baseline to 15 weeks, and 1 year
Title
Changes in the lenght of telomeres in white blood cells
Description
Telomeres (kilobase) pair
Time Frame
baseline to 15 weeks, and 1 year
Title
Change in exercise capacity
Description
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.
Time Frame
baseline to 15 weeks
Title
Experiences of the interventions, facilitators and barriers
Description
Bespoke questionnaire, only for intervention groups. Results will be presented descriptively question by question.
Time Frame
baseline to 15 weeks
Title
Adherence to the interventions
Description
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.
Time Frame
baseline to 15 weeks
Title
Muscle strength
Description
For strength training group only, measured using 8 repetition-maximum tests.
Time Frame
baseline to 15 weeks
Title
Adverse events
Description
Adverse events of taking part in the study
Time Frame
baseline to 15 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal women (one of: ≥ 12 months since last menstruation; amenorrhea due to intrauterine device or hysterectomy and Follicle Stimulating Hormone (FSH) >30 mIU/ml; bilateral oophorectomy; induced menopause due to chemotherapy or radiation and ≥2 years amenorrhea); ≥ 28 moderate to severe hot flushes per week during a 2-week screening period, registered through a daily VMS diary; Age ≥45 years; Physical ability to participate in strength training or high intensity aerobic exercise for 60 minutes, 3 times/week during 15 weeks; Understand Swedish orally and in writing Exclusion Criteria: Regular physical activity >30 minutes per week of vigorous intensity or ≥150 minutes of moderate intensity or combined activities representing maximum 150 minutes of moderate intensity; Use of systemic menopausal hormone therapy the last 2 months; Use of natural preparations such as herbal preparations for VMS, or other medications for VMS the last 2 months; Capillary hemoglobin <110 g/l; Blood pressure >160 mmHg systolic or >100 mmHg diastolic; Unstable medical condition with a potential to affect VMS (like unregulated thyroid disease); Medical condition that by a physician is judged not appropriate (because of potential to affect VMS or risk of injury with vigorous exercise)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna-Clara Spetz Holm, Ass prof, MD
Phone
+46101033130
Email
anna-clara.spetz.holm@liu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna-Clara Spetz Holm, Ass prof, MD
Organizational Affiliation
Region Östergötland, Linköping university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Kalmar Län
City
Kalmar
ZIP/Postal Code
S-39126
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micaela Sundell, MD, PhD
Facility Name
Region Östergötland
City
Linköping
ZIP/Postal Code
S-58185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna-Clara Spetz Holm, Ass prof, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie results in publications may be available upon reasonable request to the principal investigator
IPD Sharing Time Frame
1 year after publication.
Citations:
PubMed Identifier
31239119
Citation
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.
Results Reference
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Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women

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