NCT04420806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

June 5, 2020

Last Update Submit

November 12, 2020

Conditions

ExerciseDetrainingMuscle WeaknessMuscle Atrophy

Outcome Measures

Primary Outcomes (1)

  • Body composition

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

    From intervention end to 3 months FU

Secondary Outcomes (5)

  • Hip-/Leg extension strength

    From intervention end to 3 months FU

  • Metabolic Syndrome

    From intervention end to 3 months FU

  • Bone Mineral Density (BMD)

    From intervention end to 3 months FU

  • Menopausal symptoms

    From intervention end to 3 months FU

  • Back and joint pain

    From intervention end to 3 months FU

Study Arms (2)

HIT-exercise

ACTIVE COMPARATOR

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

Other: HIT-exercise

control

SHAM COMPARATOR

no exercise intervention that affect the present study outcomes

Other: Sham intervention

Interventions

HIT-exerciseOTHER

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

HIT-exercise
Sham interventionOTHER

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

control

Eligibility Criteria

Age48 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsearly postmenopausal status
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Erlangen, 91052, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33712920DERIVED

MeSH Terms

Conditions

Motor ActivityMuscle WeaknessMuscular Atrophy

Condition Hierarchy (Ancestors)

BehaviorMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsAtrophyPathological Conditions, Anatomical

Study Officials

  • Michael Hettchen, MSc

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors are unaware of participants group status and were not allowed to ask correspondingly
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One exercise versus one control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 9, 2020

Study Start

March 14, 2020

Primary Completion

July 30, 2020

Study Completion

October 30, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

DE(1)