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

CB147 - Physical Activity and Nutrition for Quality Ageing

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02694471
Acronym
BEDREST
Enrollment
23
Registered
2016-02-29
Start date
2012-08-31
Completion date
2015-01-31
Last updated
2016-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscular Atrophy

Keywords

Ageing, Physical inactivity, Functional decline, Reconditioning

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.

Interventions

BEHAVIORALphysical inactivity or bed rest with supervised recovery

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.

Sponsors

University of Trieste
CollaboratorOTHER
University of Udine
CollaboratorOTHER
University of Padova
CollaboratorOTHER
Università degli Studi di Ferrara
CollaboratorOTHER
University of Nottingham
CollaboratorOTHER
DLR German Aerospace Center
CollaboratorOTHER
Izola General Hospital
CollaboratorOTHER
National Institute of Public Health, Slovenia
CollaboratorOTHER_GOV
University of Primorska
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in quadriceps muscle volume (young vs. old) after 14-day bed restAt baseline and after 14-day bed rest and on 14th day of recoveryUsing MRI continous screening of single leg was performed
Change in diameter of single fibre contractions (young vs. old) after 14-day bed restbaseline and after 14-day bed rest and on 14th day of recoveryBiopsy samples were obtained from vastus lateralis muscles
Change in peak aerobic power (VO2max) (young vs. old) after 14-day bed restbaseline and after 14-day bed rest and on 14th day of recoverygraded cycling on sitting ergometer until exhaustion

Secondary

MeasureTime frameDescription
Change in force of single muscle fibre contraction (young vs. old) after 14-day bed restbaseline and after 14-day bed rest and on 14th day of recoveryBiopsy samples were obtained from vastus lateralis muscles
Change in specific force of single muscle fibre contraction (young vs. old) after 14-day bed restbaseline and after 14-day bed rest and on 14th day of recoveryBiopsy samples were obtained from vastus lateralis muscles
Change in velocity of single muscle fibre contraction (young vs. old) after 14-day bed restbaseline and after 14-day bed rest and on 14th day of recoveryBiopsy samples were obtained from vastus lateralis muscles
Change in peak knee extensor force (young vs. old) after 14-day bed restbaseline and after 14-day bed rest and on 14th day of recoveryEstimated from single leg isometric maximal voluntary contraction
Change in N-telopeptide (young vs. old) after 14-day bed restbaseline, during and after 14-day bed rest and during first 14 day of recoveryFrom urine collection
Change in gait stride length (young vs. old) after 14-day bed restbaseline and after 14-day bed rest and on 14th and 400th day of recoveryWalking through the food placement detection system
Change in insulin sensitivity (young vs. old) after 14-day bed restbaseline and after 14-day bed rest and on 14th day of recoverycollected 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 restbaseline and after 14-day bed rest and on 14th day of recoverycollected hourly for 3 hours after standard meal load
Change in lower limb explosive power (young vs. old) after 14-day bed restbaseline and after 14-day bed rest and on 14th day of recoveryestimated from bilateral efforts on explosive ergometer (EXER)
Change in C-telopeptide (young vs. old) after 14-day bed restbaseline, during and after 14-day bed rest and during first 14 day of recoveryFrom urine collection
Change is contraction time (young vs. old) after 14-day bed restbaseline and after 14-day bed rest and on 14th day of recoveryFrom Tensiomyographic response in vastus lateralis

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026