Muscular AtrophyBEDRESTNCT02694471
Effect of 14 Day Bed Rest on Health Outcomes in Young and Older Participants
A study testing physical inactivity or bed rest with supervised recovery in people with Muscular Atrophy, run by University of Primorska at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscular Atrophy
- What is being tested?
- physical inactivity or bed rest with supervised recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSlovenia
- Study dates
- Aug 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index < 28 kg/m2
- Short physical performance battery score >= 9
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscular Atrophy
- Being tested
- physical inactivity or bed rest with supervised recovery
- Keywords
- Ageing, Physical inactivity, Functional decline, Reconditioning
- Medical subject headings
- Muscular Atrophy, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical inactivity or bed rest with supervised recoveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Old group | Experimental | 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. Receives: Behavioral: physical inactivity or bed rest with supervised recovery |
| Young group | Active comparator | 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. Receives: Behavioral: physical inactivity or bed rest with supervised recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quadriceps muscle volume (young vs. old) after 14-day bed rest
Using MRI continous screening of single leg was performed
Measured: 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
Measured: 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
Measured: baseline and after 14-day bed rest and on 14th day of recovery
Secondary outcomes (11)
Change in peak knee extensor force (young vs. old) after 14-day bed rest
Estimated from single leg isometric maximal voluntary contraction
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline and after 14-day bed rest and on 14th day of recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startAug 2012
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Muscular AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Rado Pišot, PhD, Principal investigator, University of Primorska, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694471
- Sponsor's protocol ID
- PANGEA
- Acronym
- BEDREST
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data is shared among partners for various publications
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.
PubMed 26823343Jurdana 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.
PubMed 26564239Marusic 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.
PubMed 25938245Goswami 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.
PubMed 25709419
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CB147 - Physical Activity and Nutrition for Quality Ageing
- ClinicalTrials.gov ID
- NCT02694471
- Acronym / sponsor ID
- BEDREST / PANGEA
- Conditions
- Muscular Atrophy
- Keywords
- Ageing, Physical inactivity, Functional decline, Reconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- 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
- Study start
- Aug 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Old group | Experimental | Behavioral: physical inactivity or bed rest with supervised recovery16 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. |
| Young group | Active comparator | Behavioral: physical inactivity or bed rest with supervised recovery7 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index < 28 kg/m2
- Short physical performance battery score >= 9
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical inactivity or bed rest with supervised recoveryAll (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. | Behavioural | Old group, Young group |
Primary outcome
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
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
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
11 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Results publication: PubMed 26823343Pisot 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 publication: PubMed 26564239Jurdana 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 publication: PubMed 25938245Marusic 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 publication: PubMed 25709419Goswami 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.
- Individual participant dataSharing planned: No. The data is shared among partners for various publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rado Pišot, PhD principal investigator
University of Primorska, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical inactivity or bed rest with supervised recovery in people with Muscular Atrophy, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694471, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.