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Completed

NCT Number: NCT04420806

Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

While "conditioning" by exercise training has been widely evaluated, the available literature on "passive deconditioning" (i.e. forced deconditioning) is predominately limited to studies with or with almost complete mechanical and/or metabolic immobilization/sedation of the respective functional system (e.g. paralysis, bedriddenness). Vice versa, the effects of moderately long interruptions of dedicated types of exercise while maintaining everyday activity are rarely addressed. However, this topic is of high relevance, e.g. considering that breaks of health-related exercise programs due to increased family/occupational stress, vacation or temporary orthopedic limitation are rather frequent in everyday life. In the present project we aimed to determine the effects of 3 months of physical deconditioning due to COVID-19 induced lockdown after 13 month of high intensity endurance and resistance exercise in early postmenopausal women on parameters related to health and physical fitness.

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Key information

Conditions

Exercise Atrophy Behavior Detraining Motor Activity Muscle Atrophy Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

48 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg

Erlangen, 91052, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (early)postmenopausal women, ( normal menopause, 1-5 years post)
  • Osteopenia and osteoporosis (Bone Mineral Density <-1.0 SD T-Score)

Exclusion criteria

  • BMD <-4.0 SD T-Score
  • Prevalent clinical, low-trauma fractures
  • Diseases and drugs with relevant effects on bone and muscle metabolism (e.g. glucocorticoids >7.5 mg/d or bisphosphonate therapy); individual case assessment
  • Diseases and drugs with relevant effects on cardiometabolic risk factors (e.g. severe hypertension with corresponding medical therapy); individual case assessment
  • Severe cardiovascular events (e.g. stroke, coronary infarction) in the past.
  • Other conditions, diseases that exclude exercise training or testing

Treatment and study plan

HIT-exercise

Other

13 months of high intensity endurance and resistance exercise, 3x 45 min/week - 3 months of COVID-19 induced exercise break

Sham intervention

Other

Types of exercise (flexibility, relaxation) that did not affect the present outcomes

Primary outcomes

  1. Body composition

    Time frame: From intervention end to 3 months FU

    Body composition as determined by Dual-Energy x-Ray Absorptiometry

Secondary outcomes

  1. Hip-/Leg extension strength

    Time frame: From intervention end to 3 months FU

    Hip-/Leg extension strength as determined by an isokinetic leg press

  2. Metabolic Syndrome

    Time frame: From intervention end to 3 months FU

    cardio-metabolic risk factors summarized in the Metabolic Syndrome Z-Score according to the definition of the International Diabetes Federation

  3. Bone Mineral Density (BMD)

    Time frame: From intervention end to 3 months FU

    BMD at the lumbar spine and total hip as determined by Dual Energy x-Ray Absorptiometry

  4. Menopausal symptoms

    Time frame: From intervention end to 3 months FU

    Menopausal symptoms as determined by the "Menopausal Rating Scale" (MRS) with a scale from 0 (no complaints) to 4 (very serious complaints).

  5. Back and joint pain

    Time frame: From intervention end to 3 months FU

    Back and joint pain as determined by a standardized pain questionnaire with a scale from 0 (never) to 7 (permanent) for pain frequency or 0 (no pain) to 7 (extremely) for pain severity.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Effects of Three Months of COVID-19 Lockdown Induced Deconditioning After 13 Months of High Intensity Exercise Training in Early Postmenopausal Women

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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