Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women

NCT06030388 | Recruiting

• 1 other identifier: START2022-05030-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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:

1. 1.strength training
2. 2.high-intensity aerobic training
3. 3.untreated control group.

Conditions

Postmenopausal Symptoms; Hot Flashes

Keywords

aerobic training; strength training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• Frequency of moderate and severe hot flushes

  baseline to 6 months, 1, 2 and 5 years

• Severity of hot flushes

  baseline to 15 weeks, 6 months, 1, 2 and 5 years

• Generic health-related quality of life

  baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention

• Women specific health-related quality of life

  baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention

• Physical activity levels

  baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention

Study Arms (3)

Strength training

ACTIVE COMPARATOR

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.

Other: Strength training

High-intensity aerobic training

ACTIVE COMPARATOR

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.

Other: High-intensity aerobic training

Control group

NO INTERVENTION

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.

Interventions

Strength training OTHER

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.

Strength training

High-intensity aerobic training OTHER

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

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Linkoeping University: lead
• Region Östergötland: collaborator
• Länssjukhuset i Kalmar län: collaborator

Study Sites (2)

Region Kalmar Län

Kalmar, S-39126, Sweden

RECRUITING

Region Östergötland

Linköping, S-58185, Sweden

RECRUITING

Related 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.

  PMID: 31239119 BACKGROUND

MeSH Terms

Conditions

Hot Flashes

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anna-Clara Spetz Holm, Ass prof, MD

  Region Östergötland, Linköping university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna-Clara Spetz Holm, Ass prof, MD

CONTACT

+46101033130; anna-clara.spetz.holm@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Medical Doctor

Model Details: Three-armed randomised trial where participants are randomised to 1) strength training, 2) high-intensity aerobic training or 3) untreated control group.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: September 11, 2023
• Study Start: September 12, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2032
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year after publication.

Locations

SE (2)