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운동을 의약으로: 약물 없이 갱년기 증상에 접근하는 방법

2026년 9월 21일 업데이트: Sofia Ryman Ryman Augustsson, Linnaeus University

운동을 의약으로: 약물을 사용하지 않는 폐경 증상 접근법

The aim of this clinical trial is to evaluate the effects of different forms of physical exercise in women experiencing menopausal symptoms. Specifically, the project investigates the effects of: (1) strength training on women's perceived menopausal symptoms; (2) dance-based exercise on women's perceived menopausal symptoms; and (3) adherence to structured, digital home-based exercise programs.

The following research questions will be addressed within the framework of the project:

Does regular strength training reduce women's perceived menopausal symptoms?

To what extent does strength training influence menopausal symptoms and sleep quality in women?

What is the level of adherence to a digital, home-based strength training program among women with menopausal symptoms?

Does regular dance-based physical activity reduce women's perceived menopausal symptoms?

To what extent does dance-based physical activity influence menopausal symptoms and sleep quality in women?

What is the level of adherence to a digital, home-based dance exercise program among women with menopausal symptoms?

Which exercise protocol-strength training or dance-based exercise-has the greatest effect on perceived menopausal symptoms?

The researchers will compare a digital, home-based strength training program with a digital, home-based dance exercise program, as well as with a control group, to determine which type of exercise has the greatest effect on menopausal symptoms and sleep quality.

Participants will:

Perform either dance-based exercise or strength training for 8 weeks, three times per week, following a structured program of approximately 30 minutes per session, or participate as part of the control group.

Complete validated questionnaires assessing menopausal health, including somatic, psychological, and sexual symptoms, as well as perceived quality of life and sleep quality, both before and after the intervention.

Maintain a training diary to monitor adherence and progression, including increases in training intensity

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This clinical trial will be conducted as a randomized controlled trial, in which participants will be randomly assigned to either an intervention group or a control group. The study will begin with a pilot phase including 45 menopausal women, who will be randomly allocated to one of three groups: (1) strength training intervention (n = 15); (2) dance-based training intervention (n = 15); or (3) control group (n = 15).

Following completion of the pilot study, a full-scale intervention trial will be conducted. The sample size for the main study will be determined by a power calculation based on the results obtained from the pilot phase.

The study will begin with an assessment of participants' menopausal health, including somatic, psychological, and sexual symptoms, as well as perceived quality of life and sleep quality. These outcomes will be measured using the Menopause Rating Scale (MRS) and the Pittsburgh Sleep Quality Index (PSQI).The training protocols will be conducted over an 8-week period, with sessions performed three times per week according to a structured program lasting approximately 30 minutes per session. Two weeks after completion of the intervention, participants will be reassessed using the same instruments, with questionnaires distributed electronically via SurveyMonkey®.

The intervention will begin with a digital introductory meeting, during which participants will receive information materials on menopausal symptoms and a detailed review of the training program and study procedures. Participants in the control group will continue their usual daily activities without any prescribed intervention throughout the 8-week study period. Participants in the control group will be assessed using both instruments on two occasions, with an 8-week interval between assessments. Upon completion of the study, control group participants will be offered access to both intervention programs, as well as the results from Studies 1 and 2.

Throughout the study period, participants will be instructed not to introduce any additional forms of exercise or make changes to existing physical activity habits. The full-scale intervention is planned to be conducted over a 15-week period with a potentially larger sample size.

연구 유형

중재적

등록 (추정된)

45

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

45년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Biological female sex
  • Age 45-55 years
  • Experiencing menopausal symptoms, defined as irregular or altered menstruation plus at least one of the following:
  • Hot flashes or sweating
  • Sleep problems
  • Mood swings or depression
  • Dry mucous membranes
  • Recurrent urinary tract infections or overactive bladder
  • Joint pain
  • Decreased libido
  • Weight gain

Exclusion Criteria:

  • Have taken medication or natural remedies for menopausal symptoms in the past 2 months
  • Menopause due to illness or surgical intervention
  • Medical conditions that contraindicate participation in the exercise intervention
  • Engaged in physical activity for ≥150 minutes per week, including ≥ 75 minutes at high intensity

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Control

No intervention
실험적: Strength training

Strength training intervention.
다른: Strength training

The strength training intervention consists of an 8-week program performed 3 times per week, with sessions lasting ~30 minutes. Designed by a licensed physiotherapist, the program targets major muscle groups and includes a warm-up followed by structured exercises.

Training uses body weight and simple household equipment, such as chairs and filled water bottles, at an intensity of 8-12 repetition maximum. Each exercise has three to four difficulty levels. Before starting, participants test and select an appropriate level for each exercise to ensure correct intensity.

Participants perform at a level allowing at least eight repetitions and progress once they can complete more than twelve. This enables individualized, progressive training. After each session, participants record the difficulty level and number of repetitions in a training diary. For the full-scale intervention, exercise selection, intensity, and volume may be adjusted, and the program will be extended to 15 weeks.
실험적: Dance-based training

Dance-based training intervention.
다른: Dance-based training

Participants in the dance-based intervention will exercise three times per week at moderate intensity, following a structured 30-minute program performed individually at home via pre-recorded sessions.

After each session, participants will complete a training diary and rate perceived exertion using the Borg RPE scale (6-20), targeting at least moderate intensity (RPE ≥ 14), adjusting effort accordingly.

The program was developed and recorded by a licensed physiotherapist, pilot-tested with a small group, and reviewed by a supervising expert who provided feedback. Participants can ask questions and receive guidance on performing the exercises.

For the full-scale intervention, exercise selection, intensity, and volume may be refined, and the program will be conducted over 15 weeks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Menopause Rating Scale (MRS)
기간: 2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8

The Menopause Rating Scale (MRS) consists of 11 items grouped into three dimensions:

  • Somatic Symptoms: Hot flashes, joint pain, and related physical complaints.
  • Psychological Symptoms: Depressive mood, irritability, anxiety, and similar issues.
  • Urogenital Symptoms: Bladder problems, vaginal dryness, and related concerns. Each item is rated on a 5-point Likert scale from 0 (not present) to 4 (very severe). The total score, calculated by summing all items, provides an overall measure of menopausal symptom severity. Thus, total score ranging from 0-44.
2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8

2차 결과 측정

결과 측정
측정값 설명
기간
Pittsburgh Sleep Quality Index (PSQI)
기간: 2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8

Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, and a global score is calculated by summing the components. Higher scores indicate poorer sleep quality. The Pittsburgh Sleep Quality Index (PSQI) generates a global score ranging from 0 to 21, where a score greater than 5 typically indicates poor sleep quality. This threshold serves as a clinical benchmark, with higher scores correlating with increased severity of sleep disturbances.
2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Linnaeus University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 11월 1일

기본 완료 (추정된)

2027년 5월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2025년 12월 16일

QC 기준을 충족하는 최초 제출

2026년 1월 9일

처음 게시됨 (실제)

2026년 1월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 21일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025-06613-01
  • 2025 (미국 NIH 보조금/계약)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다