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Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

Primary Purpose

Exercise, Detraining, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HIT-exercise
Sham intervention
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise

Eligibility Criteria

48 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

HIT-exercise

control

Arm Description

13 months of high intensity endurance and resistance exercise - 3 months of exercise break

no exercise intervention that affect the present study outcomes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hip-/Leg extension strength
Hip-/Leg extension strength as determined by an isokinetic leg press
Metabolic Syndrome
cardio-metabolic risk factors summarized in the Metabolic Syndrome Z-Score according to the definition of the International Diabetes Federation
Bone Mineral Density (BMD)
BMD at the lumbar spine and total hip as determined by Dual Energy x-Ray Absorptiometry
Menopausal symptoms
Menopausal symptoms as determined by the "Menopausal Rating Scale" (MRS) with a scale from 0 (no complaints) to 4 (very serious complaints).
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.

Full Information

First Posted
June 5, 2020
Last Updated
November 12, 2020
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04420806
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 14, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Detraining, Muscle Weakness, Muscle Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One exercise versus one control group
Masking
Outcomes Assessor
Masking Description
Outcomes assessors are unaware of participants group status and were not allowed to ask correspondingly
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIT-exercise
Arm Type
Active Comparator
Arm Description
13 months of high intensity endurance and resistance exercise - 3 months of exercise break
Arm Title
control
Arm Type
Sham Comparator
Arm Description
no exercise intervention that affect the present study outcomes
Intervention Type
Other
Intervention Name(s)
HIT-exercise
Intervention Description
13 months of high intensity endurance and resistance exercise, 3x 45 min/week - 3 months of COVID-19 induced exercise break
Intervention Type
Other
Intervention Name(s)
Sham intervention
Intervention Description
Types of exercise (flexibility, relaxation) that did not affect the present outcomes
Primary Outcome Measure Information:
Title
Body composition
Description
Body composition as determined by Dual-Energy x-Ray Absorptiometry
Time Frame
From intervention end to 3 months FU
Secondary Outcome Measure Information:
Title
Hip-/Leg extension strength
Description
Hip-/Leg extension strength as determined by an isokinetic leg press
Time Frame
From intervention end to 3 months FU
Title
Metabolic Syndrome
Description
cardio-metabolic risk factors summarized in the Metabolic Syndrome Z-Score according to the definition of the International Diabetes Federation
Time Frame
From intervention end to 3 months FU
Title
Bone Mineral Density (BMD)
Description
BMD at the lumbar spine and total hip as determined by Dual Energy x-Ray Absorptiometry
Time Frame
From intervention end to 3 months FU
Title
Menopausal symptoms
Description
Menopausal symptoms as determined by the "Menopausal Rating Scale" (MRS) with a scale from 0 (no complaints) to 4 (very serious complaints).
Time Frame
From intervention end to 3 months FU
Title
Back and joint pain
Description
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.
Time Frame
From intervention end to 3 months FU

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
early postmenopausal status
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hettchen, MSc
Organizational Affiliation
Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33712920
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.
Results Reference
derived
Links:
URL
https://www.unibo.it/en/international/european-projects-of-education-and-training/actlife-physical-activity-the-tool-to-improve-the-quality-of-life-in-osteoporosis-people
Description
website of the ACTlife project

Learn more about this trial

Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

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