Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

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

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Exercise; Muscle Atrophy; Detraining
• Intervention / Treatment: Other: HIT-exercise; Other: Sham intervention

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91052
    • Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HIT-exercise; 13 months of high intensity endurance and resistance exercise - 3 months of exercise break	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 Comparator: control; no exercise intervention that affect the present study outcomes	Other: Sham intervention; Types of exercise (flexibility, relaxation) that did not affect the present outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Body composition as determined by Dual-Energy x-Ray Absorptiometry	From intervention end to 3 months FU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip-/Leg extension strength	Hip-/Leg extension strength as determined by an isokinetic leg press	From intervention end to 3 months FU
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Michael Hettchen, MSc, Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg

Publications and helpful links

General Publications

• 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.

Helpful Links

• website of the ACTlife project

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2020
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscle Weakness; Muscular Atrophy
• Other Study ID Numbers: ER_ACTLIFE_FU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No