Disuse Atrophy (Muscle) of Lower ExtremitiesNCT05617222
The Impact of Bed Rest, Aging and NMES on Skeletal Muscle
A study testing Bed rest and Neuromuscular electrical stimulation in people with Disuse Atrophy (Muscle) of Lower Extremities and Muscle Function, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Loss of muscle mass is common phenotypic trait of muscular disuse and ageing. The loss of muscle mass affects, among others, the ability to maintain homeostasis of glucose metabolism and the energy reservoir in catabolic conditions, while also affecting mechanical muscle function which can cause detrimental… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Disuse Atrophy (Muscle) of Lower Extremities, Muscle Function, Neuromuscular Electrical Stimulation
- What is being tested?
- Bed rest and Neuromuscular electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Apr 2022to 1 Aug 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Age between 18-30 or 65-80 years
- Injury free in the lower extremities (No previous or current knee injuries or knee pain)
- Normal weight
- Consumes normal diet
Who cannot join
- Cognitive impairment affecting the ability to participate in the study.
- Health related contraindications to participating in the intervention (i.e., bed rest and/or NMES), such as eczema and rash on the lower extremities
- Smoker
- Obesity
- Not able to speak or understand Danish.
- Acute or chronic diseases such as diabetes, cancer, embolism, infection, cardio-vascular diseases
Show all 10Show fewer
- Use of medication which affects myofibrillar protein synthesis or the skeletal muscle tissue
- Use of other medication (e.g. anticoagulants, adrenal cortex hormone [within the last 3 months] etc.)
- Previous or current use of anabolic steroids
- Previous participation in research trials involving deuterium oxide or another stable isotope tracer
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, 2400
Sofie K Hansen, Mac, 22423877 ext. 0045, sofie.krarup.hansen.01@regionh.dk
About this study
Official title: The Impact of Bed Rest and Aging on Muscle Mass and Muscle Function: Effects of Neuromuscular Electrical Stimulation
Loss of muscle mass is common phenotypic trait of muscular disuse and ageing. The loss of muscle mass affects, among others, the ability to maintain homeostasis of glucose metabolism and the energy reservoir in catabolic conditions, while also affecting mechanical muscle function which can cause detrimental impairments in general functional status and hence quality of life.
However, a limited amount of research has attempted to elucidate molecular regulators of muscle mass loss following bed rest in older individuals and across genders. Consequently, the mechanistic drivers are unresolved and there are currently no effective therapeutic strategies to counteract muscle wasting and loss of function in individuals submitted to bed rest e.g. during hospitalization.
Read more
Purpose The purpose is to examine the effects of 5 days of bed rest on muscle mass, including myofibrillar protein synthesis and breakdown, and muscle function, and elucidate molecular regulators of muscle mass loss and metabolic pathways, while also investigating if potential negative effects can be counteracted by daily NeuroMuscular Electrical Stimulation (NMES) across different age and genders.
Methods The study is designed as a randomized controlled cross-over 5-day bed rest study including a group of healthy young (18-30 years) and healthy old (65-80 years) men and women.
Participants will receive daily electrical stimulation (NMES) of the thigh muscles (30 min x 3/day) on one leg (ES), while the other leg serves as a control (CON).
Participants will be tested at baseline (pre) and after (post) intervention for muscle strength, muscle power, balance, and muscle activation. Blood samples are collected at several time points and muscle biopsies are sampled pre- and post-intervention along with assessment of whole-body muscle mass and thigh muscle mass.
Scientific exposition The results from the study can potentially provide insight into the adaptive mechanisms associated with NMES training and muscular disuse on both cellular- and whole-body level. The understanding of the underlying mechanisms is crucial for the application of NMES in a therapeutic context and will furthermore help us understand the basic mechanism regulating the skeletal muscle mass during both training and muscular disuse.
Overall, the results can potentially help establishing treatments to counteract loss of muscle mass, muscle function and muscle health during periods of muscular disuse.
- Conditions
- Disuse Atrophy (Muscle) of Lower Extremities, Muscle Function, Neuromuscular Electrical Stimulation, Myofibrillar Protein Synthesis
- Being tested
- Bed rest, Neuromuscular electrical stimulation
- Medical subject headings
- Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed restOther
5 days of strict bed rest
Neuromuscular electrical stimulationOther
Unilateral neuromuscular electrical stimulation (m. Quadriceps)
| Study group | Role | What they receive |
|---|---|---|
| Bed rest- Control | Active comparator | One leg will be subjected to disuse by bed rest and will not receive further treatment during the bed rest period. Receives: Other: Bed rest |
| Bed rest + NMES | Experimental | One leg will be subjected to disuse by bed rest and will in addition receive neuromuscular electrical stimulation of the quadriceps muscle 3 times/day. Receives: Other: Bed rest; Other: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Myofiber cross-sectional area
Histochemical analysis of type I and type II myofiber cross-sectional area
Measured: Change from baseline after bed rest intervention
Assessment of myofibrillar protein synthesis
Quantification of myofibrillar protein synthesis using the stable-isotope amino acid tracer deuterium oxide (D2O)
Measured: Assessed during the period from pre-intervention biopsies (day 0, first day of bed rest) to post-intervention biopsies (day 5, last day and cessation of bed rest)
Change in maximal isometric muscle strength and superimposed twitch
Maximal isometric voluntary quadriceps strength combined with the superimposed twitch technique to assess maximal strength and voluntary muscle activation
Measured: Change from baseline after bed rest intervention
Secondary outcomes (12)
Change in total Akt protein assessed by Western blot
Assessment of Akt protein by Western Blot analysis using muscle tissue from vastus lateralis
Measured: Change from baseline after bed rest intervention
Change in total mTOR protein assessed by Western blot
Assessment of mTOR protein by Western Blot analysis using muscle tissue from vastus lateralis
Measured: Change from baseline after bed rest intervention
Change in total MuRF-1 protein assessed by Western blot
Assessment of MuRF-1 protein by Western Blot analysis using muscle tissue from vastus lateralis
Measured: Change from baseline after bed rest intervention
Change in total Atrogin-1 protein assessed by Western blot
Assessment of Atrogin-1 protein by Western Blot analysis using muscle tissue from vastus lateralis
Measured: Change from baseline after bed rest intervention
Change in total myostatin protein assessed by Western blot
Assessment of myostatin protein by Western Blot analysis using muscle tissue from vastus lateralis
Measured: Change from baseline after bed rest intervention
Change in quadriceps muscle morphology and architecture by ultrasound scan
Ultrasound scan of rectus femoris and vastus lateralis muscle thickness and of vastus lateralis pennation angle
Measured: Change from baseline after bed rest intervention
Change in body composition by DEXA scan
Assessment of whole body and regional lean mass and fat
Measured: Change from baseline after bed rest intervention
Change in leg extensor power
Muscle power of the lower extremities assessed using the Nottingham power rig
Measured: Change from baseline after bed rest intervention
Change in sway - postural balance
Measurement of displacement of center of pressure during unilateral and bilateral stance
Measured: Change from baseline after bed rest intervention
Change in triglycerides
Fasting blood samples are collected for analysis of triglycerides
Measured: Day 0, day 2, day 4 and day 5
Change in cholesterol
Fasting blood samples are collected for later analysis of cholesterol
Measured: Day 0, day 2, day 4 and day 5
Change in C-reactive protein (CRP)
Fasting blood samples are collected for analysis of CRP values
Measured: Day 0, day 2, day 4 and day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start29 Apr 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disuse Atrophy (Muscle) of Lower ExtremitiesStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are subjected to 5 days bed rest. One leg will receive 3/daily neuromuscular electrical stimulation. The contralateral leg will serve as control-leg undergo disuse only.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Suetta, Bispebjerg Hospital
- Investigators
- Charlotte Suetta, Professor, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617222
- Sponsor's protocol ID
- H-20038614
- Status last verified
- Nov 2022
- First submitted
- 22 Aug 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Bed Rest and Aging on Muscle Mass and Muscle Function: Effects of Neuromuscular Electrical Stimulation
- ClinicalTrials.gov ID
- NCT05617222
- Acronym / sponsor ID
- H-20038614
- Conditions
- Disuse Atrophy (Muscle) of Lower Extremities, Muscle Function, Neuromuscular Electrical Stimulation, Myofibrillar Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 15 Nov 2022 (actual)
- 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.
Loss of muscle mass is common phenotypic trait of muscular disuse and ageing. The loss of muscle mass affects, among others, the ability to maintain homeostasis of glucose metabolism and the energy reservoir in catabolic conditions, while also affecting mechanical muscle function which can cause detrimental impairments in general functional status and hence quality of life.
However, a limited amount of research has attempted to elucidate molecular regulators of muscle mass loss following bed rest in older individuals and across genders. Consequently, the mechanistic drivers are unresolved and there are currently no effective therapeutic strategies to counteract muscle wasting and loss of function in individuals submitted to bed rest e.g. during hospitalization.
Purpose The purpose is to examine the effects of 5 days of bed rest on muscle mass, including myofibrillar protein synthesis and breakdown, and muscle function, and elucidate molecular regulators of muscle mass loss and metabolic pathways, while also investigating if potential negative effects can be counteracted by daily NeuroMuscular Electrical Stimulation (NMES) across different age and genders.
Methods The study is designed as a randomized controlled cross-over 5-day bed rest study including a group of healthy young (18-30 years) and healthy old (65-80 years) men and women.
Participants will receive daily electrical stimulation (NMES) of the thigh muscles (30 min x 3/day) on one leg (ES), while the other leg serves as a control (CON).
Participants will be tested at baseline (pre) and after (post) intervention for muscle strength, muscle power, balance, and muscle activation. Blood samples are collected at several time points and muscle biopsies are sampled pre- and post-intervention along with assessment of whole-body muscle mass and thigh muscle mass.
Scientific exposition The results from the study can potentially provide insight into the adaptive mechanisms associated with NMES training and muscular disuse on both cellular- and whole-body level. The understanding of the underlying mechanisms is crucial for the application of NMES in a therapeutic context and will furthermore help us understand the basic mechanism regulating the skeletal muscle mass during both training and muscular disuse.
Overall, the results can potentially help establishing treatments to counteract loss of muscle mass, muscle function and muscle health during periods of muscular disuse.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are subjected to 5 days bed rest. One leg will receive 3/daily neuromuscular electrical stimulation. The contralateral leg will serve as control-leg undergo disuse only.
| Arm | Type | Receives |
|---|---|---|
| Bed rest- Control | Active comparator | Other: Bed restOne leg will be subjected to disuse by bed rest and will not receive further treatment during the bed rest period. |
| Bed rest + NMES | Experimental | Other: Bed rest, Other: Neuromuscular electrical stimulationOne leg will be subjected to disuse by bed rest and will in addition receive neuromuscular electrical stimulation of the quadriceps muscle 3 times/day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy
- Age between 18-30 or 65-80 years
- Injury free in the lower extremities (No previous or current knee injuries or knee pain)
- Normal weight
- Consumes normal diet
Key exclusion criteria (10 listed)
- Cognitive impairment affecting the ability to participate in the study.
- Health related contraindications to participating in the intervention (i.e., bed rest and/or NMES), such as eczema and rash on the lower extremities
- Smoker
- Obesity
- Not able to speak or understand Danish.
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 |
|---|---|---|
| Bed rest5 days of strict bed rest | Other | Bed rest + NMES, Bed rest- Control |
| Neuromuscular electrical stimulationUnilateral neuromuscular electrical stimulation (m. Quadriceps) | Other | Bed rest + NMES |
Primary outcome
Change in Myofiber cross-sectional area
Time frame: Change from baseline after bed rest intervention
Histochemical analysis of type I and type II myofiber cross-sectional area
Assessment of myofibrillar protein synthesis
Time frame: Assessed during the period from pre-intervention biopsies (day 0, first day of bed rest) to post-intervention biopsies (day 5, last day and cessation of bed rest)
Quantification of myofibrillar protein synthesis using the stable-isotope amino acid tracer deuterium oxide (D2O)
Change in maximal isometric muscle strength and superimposed twitch
Time frame: Change from baseline after bed rest intervention
Maximal isometric voluntary quadriceps strength combined with the superimposed twitch technique to assess maximal strength and voluntary muscle activation
12 secondary outcomes
Change in total Akt protein assessed by Western blot
Time frame: Change from baseline after bed rest intervention
Change in total mTOR protein assessed by Western blot
Time frame: Change from baseline after bed rest intervention
Change in total MuRF-1 protein assessed by Western blot
Time frame: Change from baseline after bed rest intervention
Change in total Atrogin-1 protein assessed by Western blot
Time frame: Change from baseline after bed rest intervention
Change in total myostatin protein assessed by Western blot
Time frame: Change from baseline after bed rest intervention
Change in quadriceps muscle morphology and architecture by ultrasound scan
Time frame: Change from baseline after bed rest intervention
Change in body composition by DEXA scan
Time frame: Change from baseline after bed rest intervention
Change in leg extensor power
Time frame: Change from baseline after bed rest intervention
Change in sway - postural balance
Time frame: Change from baseline after bed rest intervention
Change in triglycerides
Time frame: Day 0, day 2, day 4 and day 5
Change in cholesterol
Time frame: Day 0, day 2, day 4 and day 5
Change in C-reactive protein (CRP)
Time frame: Day 0, day 2, day 4 and day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
Related trials for Disuse Atrophy (Muscle) of Lower Extremities
Not yet recruiting
Effect of Knee Position on Muscle Loss During Leg Immobilization
Muscle Atrophy, Disuse Atrophy
Recruiting
Effect of Dietary Nitrate on Immobilization-induced Changes in Skeletal Muscle in Young Healthy Men
Mitochondrial Energetics, Dietary Nitrate
Active, not recruiting
The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture
Hip Fractures, Muscle Atrophy
Recruiting
Muscle Response to Different Amounts of Dietary Protein During Leg Immobilization
Muscle Disuse, Muscle Disuse Atrophy
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.
Charlotte Suetta, Professor principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed rest and Neuromuscular electrical stimulation in people with Disuse Atrophy (Muscle) of Lower Extremities and Muscle Function, run by Bispebjerg Hospital at 1 site in Denmark.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Nov 2022. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofie K Hansen (0045 22423877, sofie.krarup.hansen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Myofiber cross-sectional area (time frame: Change from baseline after bed rest intervention). 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?
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 15 Nov 2022.