Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

Study Overview
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Brief Summary
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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.

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

Conditions
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Exercise, Detraining, Muscle Weakness, Muscle Atrophy

Intervention / Treatment
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* Other: HIT-exercise
* Other: Sham intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 48 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One exercise versus one control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIT-exercise<br>13 months of high intensity endurance and resistance exercise - 3 months of exercise break | Other: HIT-exercise<br>* 13 months of high intensity endurance and resistance exercise, 3x 45 min/week - 3 months of COVID-19 induced exercise break<br>|
| Sham Comparator: control<br>no exercise intervention that affect the present study outcomes | Other: Sham intervention<br>* Types of exercise (flexibility, relaxation) that did not affect the present outcomes<br>|

What is the study measuring?
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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 |