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

Muscular Atrophy Clinical Trial

— BEDREST  

Official title:

CB147 - Physical Activity and Nutrition for Quality Ageing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694471
• Other study ID #: PANGEA
• Status: Completed
• Phase: N/A
• First received: February 18, 2016
• Last updated: February 29, 2016
• Start date: August 2012
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Muscular Atrophy

Intervention

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.

Locations

Country	Name	City	State
Slovenia	Orthopaedic Hospital Valdoltra	Ankaran

Sponsors (9)

Lead Sponsor	Collaborator
University of Primorska	DLR German Aerospace Center, Izola General hospital, National Institute of Public Health of the Republic of Slovenia, Università degli Studi di Ferrara, University of Nottingham, University of Padua, University of Trieste, University of Udine

Country where clinical trial is conducted

Slovenia, 

References & Publications (4)

Goswami N, Kavcic V, Marusic U, Simunic B, Rössler 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 — View Citation

Jurdana M, Jenko-Pražnikar Z, Mohorko N, Petelin A, Jakus T, Šimunic B, Pišot 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 20 — View Citation

Marusic U, Kavcic V, Giordani B, Gerževic M, Meeusen R, Pišot 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):334-40. doi: 10.1037/pag0000021. Epu — View Citation

Pisot R, Marusic U, Biolo G, Mazzucco S, Lazzer S, Grassi B, Reggiani C, Toniolo L, di Prampero PE, Passaro A, Narici MV, Mohammed S, Rittweger J, Gasparini M, Gabrijelcic M, Simunic B. Greater loss in muscle mass and function but smaller metabolic altera — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes

External Links

•   Home page of PANGEA project