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Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04420806
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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.

Condition or disease Intervention/treatment Phase
Exercise Detraining Muscle Weakness Muscle Atrophy Other: HIT-exercise Other: Sham intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One exercise versus one control group
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors are unaware of participants group status and were not allowed to ask correspondingly
Primary Purpose: Treatment
Official Title: Effects of Three Months of COVID-19 Lockdown Induced Deconditioning After 13 Months of High Intensity Exercise Training in Early Postmenopausal Women
Actual Study Start Date : March 14, 2020
Actual Primary Completion Date : July 30, 2020
Actual Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Body composition [ Time Frame: From intervention end to 3 months FU ]
    Body composition as determined by Dual-Energy x-Ray Absorptiometry


Secondary Outcome Measures :
  1. Hip-/Leg extension strength [ Time Frame: From intervention end to 3 months FU ]
    Hip-/Leg extension strength as determined by an isokinetic leg press

  2. Metabolic Syndrome [ Time Frame: From intervention end to 3 months FU ]
    cardio-metabolic risk factors summarized in the Metabolic Syndrome Z-Score according to the definition of the International Diabetes Federation

  3. Bone Mineral Density (BMD) [ Time Frame: From intervention end to 3 months FU ]
    BMD at the lumbar spine and total hip as determined by Dual Energy x-Ray Absorptiometry

  4. Menopausal symptoms [ Time Frame: From intervention end to 3 months FU ]
    Menopausal symptoms as determined by the "Menopausal Rating Scale" (MRS) with a scale from 0 (no complaints) to 4 (very serious complaints).

  5. Back and joint pain [ Time Frame: From intervention end to 3 months FU ]
    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.



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Ages Eligible for Study:   48 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   early postmenopausal status
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420806


Locations
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Germany
Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Michael Hettchen, MSc Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg
Additional Information:
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT04420806    
Other Study ID Numbers: ER_ACTLIFE_FU
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Atrophy
Atrophy
Pathological Conditions, Anatomical
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes