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ExerciseNCT04420806

Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

A study testing HIT-exercise in people with Exercise and Detraining, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 48 to 60 years, women only
Conditions the study is for
Exercise, Detraining, Muscle Weakness
What is being tested?
HIT-exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteGermany
Study dates
14 Mar 2020to 30 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 48 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Erlangen, 91052

Other trials in Germany

About this study

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

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.

Being tested
HIT-exercise, Sham intervention
Medical subject headings
Motor Activity, Muscle Weakness, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIT-exerciseOther

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

  • Sham interventionOther

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

Study groups in NCT04420806
Study groupRoleWhat they receive
HIT-exerciseActive comparator13 months of high intensity endurance and resistance exercise - 3 months of exercise break
Receives: Other: HIT-exercise
controlSham comparatorno exercise intervention that affect the present study outcomes
Receives: Other: Sham intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body composition

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

    Measured: From intervention end to 3 months FU

Secondary outcomes (5)

  1. Hip-/Leg extension strength

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

    Measured: 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

    Measured: 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

    Measured: 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).

    Measured: 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.

    Measured: From intervention end to 3 months FU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start14 Mar 2020
  3. Primary completion30 Jul 2020
  4. Study completion30 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
One exercise versus one control group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04420806
Sponsor's protocol ID
ER_ACTLIFE_FU
Status last verified
Nov 2020
First submitted
5 Jun 2020
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing HIT-exercise in people with Exercise and Detraining, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition (time frame: From intervention end to 3 months FU). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04420806, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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