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Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

NCT ID: NCT04420806

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-14

Study Completion Date

2020-10-30

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.

Detailed Description

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Conditions

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Exercise Detraining Muscle Weakness Muscle Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One exercise versus one control group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessors are unaware of participants group status and were not allowed to ask correspondingly

Study Groups

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HIT-exercise

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

Group Type ACTIVE_COMPARATOR

HIT-exercise

Intervention Type OTHER

13 months of high intensity endurance and resistance exercise, 3x 45 min/week - 3 months of COVID-19 induced exercise break

control

no exercise intervention that affect the present study outcomes

Group Type SHAM_COMPARATOR

Sham intervention

Intervention Type OTHER

Types of exercise (flexibility, relaxation) that did not affect the present outcomes

Interventions

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HIT-exercise

13 months of high intensity endurance and resistance exercise, 3x 45 min/week - 3 months of COVID-19 induced exercise break

Intervention Type OTHER

Sham intervention

Types of exercise (flexibility, relaxation) that did not affect the present outcomes

Intervention Type OTHER

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
Minimum Eligible Age

48 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Hettchen, MSc

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg

Locations

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

Erlangen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 33712920 (View on PubMed)

Other Identifiers

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ER_ACTLIFE_FU

Identifier Type: -

Identifier Source: org_study_id