Clinical trial NCT04420806: Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women
Official title: Effects of Three Months of COVID-19 Lockdown Induced Deconditioning After 13 Months of High Intensity Exercise Training in Early Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Detraining
Muscle Weakness
Muscle Atrophy
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 21
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One exercise versus one control group
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Body composition
timeFrame: From intervention end to 3 months FU
Secondary outcomes:
measure: Hip-/Leg extension strength
timeFrame: From intervention end to 3 months FU
measure: Metabolic Syndrome
timeFrame: From intervention end to 3 months FU
measure: Bone Mineral Density (BMD)
timeFrame: From intervention end to 3 months FU
measure: Menopausal symptoms
timeFrame: From intervention end to 3 months FU
measure: Back and joint pain
timeFrame: From intervention end to 3 months FU
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg
Study officials:
affiliation: Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg
name: Michael Hettchen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kemmler W, Hettchen M, Kohl M, Murphy M, Bragonzoni L, Julin M, Risto T, von Stengel S. Detraining Effects on Musculoskeletal Parameters in Early Postmenopausal Osteopenic Women: 3-Month Follow-Up of the Randomized Controlled ACTLIFE Study. Calcif Tissue Int. 2021 Jul;109(1):1-11. doi: 10.1007/s00223-021-00829-0. Epub 2021 Mar 12.