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Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

Sponsor
University of Erlangen-Nürnberg Medical School (Other)
Overall Status
Completed
CT.gov ID
NCT04420806
Collaborator
(none)
21
Enrollment
1
Location
2
Arms
7.6
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: HIT-exercise
  • Other: Sham intervention
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
One exercise versus one control groupOne 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 :
Mar 14, 2020
Actual Primary Completion Date :
Jul 30, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Body composition [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 [From intervention end to 3 months FU]

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

  2. Metabolic Syndrome [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) [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
48 Years to 60 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg Erlangen Germany 91052

Sponsors and Collaborators

  • University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Michael Hettchen, MSc, Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT04420806
Other Study ID Numbers:
  • ER_ACTLIFE_FU
First Posted:
Jun 9, 2020
Last Update Posted:
Nov 13, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Muscle Weakness
Muscular Atrophy

Study Results

No Results Posted as of Nov 13, 2020