NCT02694471

Brief Summary

This investigation aimed to compare the response of older adult and young men to 14 day bed-rest and subsequent 28 day rehabilitation. Sixteen older (OM: 55-65 years) and seven young men (YM: 18-30 years) were exposed to 14-day bed rest (BR) followed by 14-day rehabilitation (R), and 400-day of R. Quadriceps muscle volume, force and explosive power of leg extensors, single fiber isometric force, peak aerobic power, gait stride length, and several metabolic were measured before and after BR and after R.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration 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

August 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

February 18, 2016

Last Update Submit

February 29, 2016

Conditions

Muscular Atrophy

Keywords

AgeingPhysical inactivityFunctional declineReconditioning

Outcome Measures

Primary Outcomes (3)

  • Change in quadriceps muscle volume (young vs. old) after 14-day bed rest

    Using MRI continous screening of single leg was performed

    At baseline and after 14-day bed rest and on 14th day of recovery

  • Change in diameter of single fibre contractions (young vs. old) after 14-day bed rest

    Biopsy samples were obtained from vastus lateralis muscles

    baseline and after 14-day bed rest and on 14th day of recovery

  • Change in peak aerobic power (VO2max) (young vs. old) after 14-day bed rest

    graded cycling on sitting ergometer until exhaustion

    baseline and after 14-day bed rest and on 14th day of recovery

Secondary Outcomes (11)

  • Change in peak knee extensor force (young vs. old) after 14-day bed rest

    baseline and after 14-day bed rest and on 14th day of recovery

  • Change in lower limb explosive power (young vs. old) after 14-day bed rest

    baseline and after 14-day bed rest and on 14th day of recovery

  • Change in gait stride length (young vs. old) after 14-day bed rest

    baseline and after 14-day bed rest and on 14th and 400th day of recovery

  • Change in insulin sensitivity (young vs. old) after 14-day bed rest

    baseline and after 14-day bed rest and on 14th day of recovery

  • Change in area-under-the curve (AUC) of triglycerides plasma concentration (young vs. old) after 14-day bed rest

    baseline and after 14-day bed rest and on 14th day of recovery

  • +6 more secondary outcomes

Study Arms (2)

Old group

EXPERIMENTAL

16 old participants (55-65 years) were included in physical inactivity or bed rest with supervised recovery intervent and underwent 14-day of bed rest. Bed rest was followed by 28-day recovery. During the bed rest participants will remain 24-hour horizontal with all daily activities performed lying in a bed. No social isolation will be forced. During the recovery participants will 3-times weekly per 75 minutes perform guided exercises to achieve baseline level.

Behavioral: physical inactivity or bed rest with supervised recovery

Young group

ACTIVE COMPARATOR

7 young participants (18-30 years) were included in physical inactivity or bed rest with supervised recovery intervent and underwent 14-day of bed rest. Bed rest was followed by 28-day recovery. During the bed rest participants will remain 24-hour horizontal with all daily activities performed lying in a bed. No social isolation will be forced. During the recovery participants will 3-times weekly per 75 minutes perform guided exercises to achieve baseline level.

Behavioral: physical inactivity or bed rest with supervised recovery

Interventions

physical inactivity or bed rest with supervised recoveryBEHAVIORAL

All (older and younger) participants underwent 14 day of horizontal bed rest with all 24 hour daily activities were performed lying in a bed. Maximal one pillow was allowed. 28-day supervised recovery was performed 3 times weekly for 75 minutes/session.

Old groupYoung group

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index \< 28 kg/m2
  • Short physical performance battery score \>= 9

You may not qualify if:

  • smoking;
  • regular alcohol consumption;
  • ferromagnetic implants;
  • history of deep vein thrombosis with D-dimer \> 500 μg·L-1;
  • acute or chronic skeletal, neuromuscular, metabolic and cardiovascular disease conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Hospital Valdoltra

Ankaran, 6280, Slovenia

Location

Related Publications (4)

  • Pisot R, Marusic U, Biolo G, Mazzucco S, Lazzer S, Grassi B, Reggiani C, Toniolo L, di Prampero PE, Passaro A, Narici M, Mohammed S, Rittweger J, Gasparini M, Gabrijelcic Blenkus M, Simunic B. Greater loss in muscle mass and function but smaller metabolic alterations in older compared with younger men following 2 wk of bed rest and recovery. J Appl Physiol (1985). 2016 Apr 15;120(8):922-9. doi: 10.1152/japplphysiol.00858.2015. Epub 2016 Jan 28.

    PMID: 26823343RESULT

  • Jurdana M, Jenko-Praznikar Z, Mohorko N, Petelin A, Jakus T, Simunic B, Pisot R. Impact of 14-day bed rest on serum adipokines and low-grade inflammation in younger and older adults. Age (Dordr). 2015 Dec;37(6):116. doi: 10.1007/s11357-015-9848-z. Epub 2015 Nov 13.

    PMID: 26564239RESULT

  • Marusic U, Kavcic V, Giordani B, Gerzevic M, Meeusen R, Pisot R. Computerized spatial navigation training during 14 days of bed rest in healthy older adult men: Effect on gait performance. Psychol Aging. 2015 Jun;30(2):334-340. doi: 10.1037/pag0000021. Epub 2015 May 4.

    PMID: 25938245RESULT

  • Goswami N, Kavcic V, Marusic U, Simunic B, Rossler A, Hinghofer-Szalkay H, Pisot R. Effect of computerized cognitive training with virtual spatial navigation task during bed rest immobilization and recovery on vascular function: a pilot study. Clin Interv Aging. 2015 Feb 10;10:453-9. doi: 10.2147/CIA.S76028. eCollection 2015.

    PMID: 25709419RESULT

MeSH Terms

Conditions

Muscular AtrophySedentary Behavior

Interventions

Bed Rest

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Rado Pišot, PhD

    University of Primorska, Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

February 29, 2016

Study Start

August 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

March 1, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

The data is shared among partners for various publications

Locations

SL(1)