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

CB147 - Physical Activity and Nutrition for Quality Ageing

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.

Study Overview

• Status: Completed
• Conditions: Muscular Atrophy
• Intervention / Treatment: Behavioral: physical inactivity or bed rest with supervised recovery

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ankaran, Slovenia, 6280
    • Orthopaedic Hospital Valdoltra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Old group; 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; 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.
Active Comparator: Young group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peak knee extensor force (young vs. old) after 14-day bed rest	Estimated from single leg isometric maximal voluntary contraction	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	estimated from bilateral efforts on explosive ergometer (EXER)	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	Walking through the food placement detection system	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	collected hourly for 6 hours after standard meal load as a measure of insulin sensitivity index	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	collected hourly for 3 hours after standard meal load	baseline and after 14-day bed rest and on 14th day of recovery
Change in N-telopeptide (young vs. old) after 14-day bed rest	From urine collection	baseline, during and after 14-day bed rest and during first 14 day of recovery
Change in C-telopeptide (young vs. old) after 14-day bed rest	From urine collection	baseline, during and after 14-day bed rest and during first 14 day of recovery
Change is contraction time (young vs. old) after 14-day bed rest	From Tensiomyographic response in vastus lateralis	baseline and after 14-day bed rest and on 14th day of recovery
Change in force of single muscle fibre contraction (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 specific force of single muscle fibre contraction (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 velocity of single muscle fibre contraction (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

Collaborators and Investigators

• Sponsor: University of Primorska
• Collaborators: University of Nottingham; University of Trieste; University of Udine; University of Padova; Università degli Studi di Ferrara; DLR German Aerospace Center; Izola General Hospital; National Institute of Public Health, Slovenia
• Investigators: Principal Investigator: Rado Pišot, PhD, University of Primorska, Slovenia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Estimate): March 1, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Functional decline; Ageing; Physical inactivity; Reconditioning
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy
• Other Study ID Numbers: PANGEA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data is shared among partners for various publications

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No