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Completed

NCT Number: NCT02694471

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Hospital Valdoltra

Ankaran, 6280, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

physical inactivity or bed rest with supervised recovery

Behavioral

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 outcomes

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

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

    Using MRI continous screening of single leg was performed

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

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

    Biopsy samples were obtained from vastus lateralis muscles

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

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

    graded cycling on sitting ergometer until exhaustion

Secondary outcomes

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

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

    Estimated from single leg isometric maximal voluntary contraction

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

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

    estimated from bilateral efforts on explosive ergometer (EXER)

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

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

    Walking through the food placement detection system

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

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

    collected hourly for 6 hours after standard meal load as a measure of insulin sensitivity index

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

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

    collected hourly for 3 hours after standard meal load

  6. Change in N-telopeptide (young vs. old) after 14-day bed rest

    Time frame: baseline, during and after 14-day bed rest and during first 14 day of recovery

    From urine collection

  7. Change in C-telopeptide (young vs. old) after 14-day bed rest

    Time frame: baseline, during and after 14-day bed rest and during first 14 day of recovery

    From urine collection

  8. Change is contraction time (young vs. old) after 14-day bed rest

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

    From Tensiomyographic response in vastus lateralis

  9. Change in force of single muscle fibre contraction (young vs. old) after 14-day bed rest

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

    Biopsy samples were obtained from vastus lateralis muscles

  10. Change in specific force of single muscle fibre contraction (young vs. old) after 14-day bed rest

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

    Biopsy samples were obtained from vastus lateralis muscles

  11. Change in velocity of single muscle fibre contraction (young vs. old) after 14-day bed rest

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

    Biopsy samples were obtained from vastus lateralis muscles

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Collaborators

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

Registry information

Official study title

CB147 - Physical Activity and Nutrition for Quality Ageing

Acronym: BEDREST

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Feb 29, 2016
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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