Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420806
• Other study ID #: ER_ACTLIFE_FU
• Status: Completed
• Phase: N/A
• Start date: March 14, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 48 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Detraining
• Exercise
• Muscle Atrophy
• Muscle Weakness
• Muscular Atrophy

Intervention

Other:
• HIT-exercise
13 months of high intensity endurance and resistance exercise, 3x 45 min/week - 3 months of COVID-19 induced exercise break
• Sham intervention
Types of exercise (flexibility, relaxation) that did not affect the present outcomes

Locations

Country	Name	City	State
Germany	Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	Body composition as determined by Dual-Energy x-Ray Absorptiometry	From intervention end to 3 months FU
Secondary	Hip-/Leg extension strength	Hip-/Leg extension strength as determined by an isokinetic leg press	From intervention end to 3 months FU
Secondary	Metabolic Syndrome	cardio-metabolic risk factors summarized in the Metabolic Syndrome Z-Score according to the definition of the International Diabetes Federation	From intervention end to 3 months FU
Secondary	Bone Mineral Density (BMD)	BMD at the lumbar spine and total hip as determined by Dual Energy x-Ray Absorptiometry	From intervention end to 3 months FU
Secondary	Menopausal symptoms	Menopausal symptoms as determined by the "Menopausal Rating Scale" (MRS) with a scale from 0 (no complaints) to 4 (very serious complaints).	From intervention end to 3 months FU
Secondary	Back and joint pain	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.	From intervention end to 3 months FU

External Links

•   website of the ACTlife project