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Effect of 14 Day Bed Rest on Health Outcomes in Young and Older Participants (BEDREST)

Primary Purpose

Muscular Atrophy

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
physical inactivity or bed rest with supervised recovery
Sponsored by
University of Primorska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscular Atrophy focused on measuring Ageing, Physical inactivity, Functional decline, Reconditioning

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Orthopaedic Hospital Valdoltra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Old group

Young group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in quadriceps muscle volume (young vs. old) after 14-day bed rest
Using MRI continous screening of single leg was performed
Change in diameter of single fibre contractions (young vs. old) after 14-day bed rest
Biopsy samples were obtained from vastus lateralis muscles
Change in peak aerobic power (VO2max) (young vs. old) after 14-day bed rest
graded cycling on sitting ergometer until exhaustion

Secondary Outcome Measures

Change in peak knee extensor force (young vs. old) after 14-day bed rest
Estimated from single leg isometric maximal voluntary contraction
Change in lower limb explosive power (young vs. old) after 14-day bed rest
estimated from bilateral efforts on explosive ergometer (EXER)
Change in gait stride length (young vs. old) after 14-day bed rest
Walking through the food placement detection system
Change in insulin sensitivity (young vs. old) after 14-day bed rest
collected hourly for 6 hours after standard meal load as a measure of insulin sensitivity index
Change in area-under-the curve (AUC) of triglycerides plasma concentration (young vs. old) after 14-day bed rest
collected hourly for 3 hours after standard meal load
Change in N-telopeptide (young vs. old) after 14-day bed rest
From urine collection
Change in C-telopeptide (young vs. old) after 14-day bed rest
From urine collection
Change is contraction time (young vs. old) after 14-day bed rest
From Tensiomyographic response in vastus lateralis
Change in force of single muscle fibre contraction (young vs. old) after 14-day bed rest
Biopsy samples were obtained from vastus lateralis muscles
Change in specific force of single muscle fibre contraction (young vs. old) after 14-day bed rest
Biopsy samples were obtained from vastus lateralis muscles
Change in velocity of single muscle fibre contraction (young vs. old) after 14-day bed rest
Biopsy samples were obtained from vastus lateralis muscles

Full Information

First Posted
February 18, 2016
Last Updated
February 29, 2016
Sponsor
University of Primorska
Collaborators
University of Trieste, University of Udine, University of Padova, Università degli Studi di Ferrara, University of Nottingham, DLR German Aerospace Center, Izola General Hospital, National Institute of Public Health, Slovenia
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1. Study Identification

Unique Protocol Identification Number
NCT02694471
Brief Title
Effect of 14 Day Bed Rest on Health Outcomes in Young and Older Participants
Acronym
BEDREST
Official Title
CB147 - Physical Activity and Nutrition for Quality Ageing
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Primorska
Collaborators
University of Trieste, University of Udine, University of Padova, Università degli Studi di Ferrara, University of Nottingham, DLR German Aerospace Center, Izola General Hospital, National Institute of Public Health, Slovenia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Twenty-three healthy men, of which 7 young (YM; aged 18-30 years) and 16 older adults (OM; aged 55-65 years) were recruited for the study. All participants underwent medical examination and routine blood and urine analysis. Exclusion criteria were: 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; pulmonary embolism. Participants were informed of the purpose, procedures and potential risk of the study before signing the informed consent. The study was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki and was approved by the National Ethical Committee of the Slovenian Ministry of Health on April 17, 2012. The study was conducted in controlled medical environment of the Orthopedic Hospital of Valdoltra, Slovenia. The participants were housed in standard air conditioned hospital rooms and were under constant surveillance with 24-hour medical care. For 14 days, the participants performed all daily activities in bed and received eucaloric controlled meals three times a day. Dietary energy requirements were designed for each subject multiplying resting energy expenditure by factors 1.2 and 1.4 in BR and ambulatory period, respectively. The resting energy expenditure was calculated as done in previous studies. The macronutrient food content set at 60% of carbohydrates, 25% fat, and 15% of proteins, according to the scheme of the so called "mediterranean diet" and adopted also in previous bed rest protocols. Energy balance was checked weekly by fat mass assessment. The daily protein intake was 1.1-1.25 g kg-1 in both groups, in BR and recovery period respectively, except the subgroups of OM who received a supplementation (see below). After the BR, participants underwent a rehabilitation protocol (R) that consisted of 4-week supervised multimodal exercise program with 3 sessions per week. In each session, participants performed 12-minute warm-up, 15-20 minutes of balance and strength training, and 20-30 minutes of endurance training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Atrophy
Keywords
Ageing, Physical inactivity, Functional decline, Reconditioning

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Old group
Arm Type
Experimental
Arm Description
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.
Arm Title
Young group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
physical inactivity or bed rest with supervised recovery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in quadriceps muscle volume (young vs. old) after 14-day bed rest
Description
Using MRI continous screening of single leg was performed
Time Frame
At baseline and after 14-day bed rest and on 14th day of recovery
Title
Change in diameter of single fibre contractions (young vs. old) after 14-day bed rest
Description
Biopsy samples were obtained from vastus lateralis muscles
Time Frame
baseline and after 14-day bed rest and on 14th day of recovery
Title
Change in peak aerobic power (VO2max) (young vs. old) after 14-day bed rest
Description
graded cycling on sitting ergometer until exhaustion
Time Frame
baseline and after 14-day bed rest and on 14th day of recovery
Secondary Outcome Measure Information:
Title
Change in peak knee extensor force (young vs. old) after 14-day bed rest
Description
Estimated from single leg isometric maximal voluntary contraction
Time Frame
baseline and after 14-day bed rest and on 14th day of recovery
Title
Change in lower limb explosive power (young vs. old) after 14-day bed rest
Description
estimated from bilateral efforts on explosive ergometer (EXER)
Time Frame
baseline and after 14-day bed rest and on 14th day of recovery
Title
Change in gait stride length (young vs. old) after 14-day bed rest
Description
Walking through the food placement detection system
Time Frame
baseline and after 14-day bed rest and on 14th and 400th day of recovery
Title
Change in insulin sensitivity (young vs. old) after 14-day bed rest
Description
collected hourly for 6 hours after standard meal load as a measure of insulin sensitivity index
Time Frame
baseline and after 14-day bed rest and on 14th day of recovery
Title
Change in area-under-the curve (AUC) of triglycerides plasma concentration (young vs. old) after 14-day bed rest
Description
collected hourly for 3 hours after standard meal load
Time Frame
baseline and after 14-day bed rest and on 14th day of recovery
Title
Change in N-telopeptide (young vs. old) after 14-day bed rest
Description
From urine collection
Time Frame
baseline, during and after 14-day bed rest and during first 14 day of recovery
Title
Change in C-telopeptide (young vs. old) after 14-day bed rest
Description
From urine collection
Time Frame
baseline, during and after 14-day bed rest and during first 14 day of recovery
Title
Change is contraction time (young vs. old) after 14-day bed rest
Description
From Tensiomyographic response in vastus lateralis
Time Frame
baseline and after 14-day bed rest and on 14th day of recovery
Title
Change in force of single muscle fibre contraction (young vs. old) after 14-day bed rest
Description
Biopsy samples were obtained from vastus lateralis muscles
Time Frame
baseline and after 14-day bed rest and on 14th day of recovery
Title
Change in specific force of single muscle fibre contraction (young vs. old) after 14-day bed rest
Description
Biopsy samples were obtained from vastus lateralis muscles
Time Frame
baseline and after 14-day bed rest and on 14th day of recovery
Title
Change in velocity of single muscle fibre contraction (young vs. old) after 14-day bed rest
Description
Biopsy samples were obtained from vastus lateralis muscles
Time Frame
baseline and after 14-day bed rest and on 14th day of recovery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index < 28 kg/m2 Short physical performance battery score >= 9 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rado Pišot, PhD
Organizational Affiliation
University of Primorska, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Hospital Valdoltra
City
Ankaran
ZIP/Postal Code
6280
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data is shared among partners for various publications
Citations:
PubMed Identifier
26823343
Citation
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.
Results Reference
result
PubMed Identifier
26564239
Citation
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.
Results Reference
result
PubMed Identifier
25938245
Citation
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.
Results Reference
result
PubMed Identifier
25709419
Citation
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.
Results Reference
result

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Effect of 14 Day Bed Rest on Health Outcomes in Young and Older Participants

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