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CompletedNCT04420806Updated Nov 13, 2020

Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

An interventional study of HIT-exercise and Sham intervention in Exercise, Detraining and Muscle Weakness, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 1 site in Germany. Open to female participants aged 48 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
48 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Exercise
  • Detraining
  • Muscle Weakness
  • Muscle Atrophy
03

In context

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's enrollment of 21 is below the median of 46 across 444 interventional studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
48 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • (early)postmenopausal women, ( normal menopause, 1-5 years post)
  • Osteopenia and osteoporosis (Bone Mineral Density \<-1.0 SD T-Score)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Active comparator
    HIT-exercise

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

    Other: HIT-exercise

  • Sham comparator
    control

    no exercise intervention that affect the present study outcomes

    Other: Sham intervention

Interventions

  • OtherHIT-exercise

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

  • OtherSham intervention

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

06

What researchers measure

Primary outcomes

  1. Body composition

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

    Time frame: From intervention end to 3 months FU

Secondary outcomes

  1. Hip-/Leg extension strength

    Hip-/Leg extension strength as determined by an isokinetic leg press

    Time frame: From intervention end to 3 months FU

  2. Metabolic Syndrome

    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

  3. Bone Mineral Density (BMD)

    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

  4. Menopausal symptoms

    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

  5. 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.

    Time frame: From intervention end to 3 months FU

07

Study locations

1 site
  • Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg
    Erlangen, 91052, Germany
08

References and documents

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. PubMed 33712920 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04420806
Lead sponsor
University of Erlangen-Nürnberg Medical School
Responsible party
Sponsor
First posted
Jun 9, 2020
Start date
Mar 14, 2020
Primary completion
Jul 30, 2020
Completion
Oct 30, 2020
Last update
Nov 13, 2020

Study contacts

Michael Hettchen, MSc
principal investigator · Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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