SarcopeniaNCT01489930
Effects of Resistance and Endurance Training on Synthesis of Individual Muscle Proteins in Young and Older Adults
A study testing Endurance exercise and Resistance exercise in people with Sarcopenia, run by Mayo Clinic at 1 site in United States.
Trial summary
Loss of skeletal muscle strength and skeletal muscle mass occurs with of aging. This are-related decline in skeletal muscle mass and skeletal muscle strength is a major underlying factor contributing to many of the metabolic disorders and frailty of the investigators rapidly expanding aging population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Endurance exercise and Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Feb 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- 18 to 30 or >65 years
- Males and Females
Who cannot join
- Regular Exercise Program
- Smoking
- Cardiometabolic Disease (diabetes, cardiovascular disease, thyroid disorders)
- Drugs known to impair metabolic function (beta blockers, steroids)
- Allergies to lidocaine
- Physical disability that precludes exercise
Trial locations and contacts
1 site in 1 country.
About this study
Loss of skeletal muscle strength and skeletal muscle mass occurs with of aging. This are-related decline in skeletal muscle mass and skeletal muscle strength is a major underlying factor contributing to many of the metabolic disorders and frailty of the investigators rapidly expanding aging population. Endurance (aerobic) and resistance exercise training programs have been shown to effectively reverse the age-related decline in metabolic and contractile muscle functions. The investigators will measure synthesis rates of individual muscle proteins in 36 each of young (18-30 yrs) and 36 older (> 65 yrs) people to determine their response to 8 weeks each of endurance, resistance, combined endurance and resistance training, or placebo exercise training.
Hypotheses.
- to measure fractional synthesis rates of multiple muscle proteins and identify those that are enhanced by an endurance exercise program
- to determine whether changes in protein synthesis in response to endurance exercise programs are dependent on age
- to measure fractional muscle synthesis rates of multiple muscle proteins and to identify those that are enhanced by a resistance exercise program
- to determine whether changes in protein synthesis in response to resistance exercise programs are dependent on age
- Conditions
- Sarcopenia
- Being tested
- Endurance exercise, Resistance exercise, Control/Combined training
- Keywords
- Exercise, Aging, Sarcopenia, Mitochondria
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance exerciseBehavioural
Participants will perform 8-weeks of endurance exercise training. Participants will train 5 days per week for 60 min at 65% of VO2 peak.
Resistance exerciseBehavioural
Participants will perform 8-weeks of resistance exercise training. Participants will train 4 days per week for ~60 min. Two days will focus on lower body resistance training and two days will focus on upper body.
Control/Combined trainingBehavioural
Participants will perform 8-weeks of no exercise (control), followed by 8-weeks of combined endurance and resistance training. Participants will endurance train 5 days per week for 30 min at 65% of VO2 peak and resistance train 4 days per week for 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Endurance Exercise | Experimental | Participants will perform 8-weeks of moderate intensity endurance (cycling) exercise Receives: Behavioral: Endurance exercise |
| Resistance Exercise | Experimental | Participants will perform 8-weeks of whole-body resistance exercise training. Receives: Behavioral: Resistance exercise |
| Control / Combined Training | Experimental | Participants will perform 8-weeks of no exercise, followed by an additional 8-weeks of combined endurance plus resistance exercise training. Receives: Behavioral: Control/Combined training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Protein Synthesis
The investigators will determine the change from baseline in skeletal muscle protein synthesis. Measurments will be performed at baseline and following 8 weeks of exercise training.
Measured: Measured at week 0 (baseline) and week 8
Secondary outcomes (1)
Mitochondrial Function
The investigators will determine the change from baseline in mitochondrial function. Measurments will be performed at baseline and following 8 weeks of exercise training.
Measured: Measured at week 0 (baseline) and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startMay 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. Sreekumaran Nair, Mayo Clinic
- Investigators
- K. Sreekumaran Nair, MD, PD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489930
- Sponsor's protocol ID
- 07-007689
- Status last verified
- Dec 2011
- First submitted
- 18 Nov 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Irving BA, Lanza IR, Henderson GC, Rao RR, Spiegelman BM, Nair KS. Combined training enhances skeletal muscle mitochondrial oxidative capacity independent of age. J Clin Endocrinol Metab. 2015 Apr;100(4):1654-63. doi: 10.1210/jc.2014-3081. Epub 2015 Jan 19.
PubMed 25599385
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance and Endurance Training on Synthesis of Individual Muscle Proteins in Young and Older Adults
- ClinicalTrials.gov ID
- NCT01489930
- Acronym / sponsor ID
- 07-007689
- Conditions
- Sarcopenia
- Keywords
- Exercise, Aging, Sarcopenia, Mitochondria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Dec 2011 (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.
Loss of skeletal muscle strength and skeletal muscle mass occurs with of aging. This are-related decline in skeletal muscle mass and skeletal muscle strength is a major underlying factor contributing to many of the metabolic disorders and frailty of the investigators rapidly expanding aging population. Endurance (aerobic) and resistance exercise training programs have been shown to effectively reverse the age-related decline in metabolic and contractile muscle functions. The investigators will measure synthesis rates of individual muscle proteins in 36 each of young (18-30 yrs) and 36 older (> 65 yrs) people to determine their response to 8 weeks each of endurance, resistance, combined endurance and resistance training, or placebo exercise training.
Hypotheses.
- to measure fractional synthesis rates of multiple muscle proteins and identify those that are enhanced by an endurance exercise program
- to determine whether changes in protein synthesis in response to endurance exercise programs are dependent on age
- to measure fractional muscle synthesis rates of multiple muscle proteins and to identify those that are enhanced by a resistance exercise program
- to determine whether changes in protein synthesis in response to resistance exercise programs are dependent on age
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endurance Exercise | Experimental | Behavioral: Endurance exerciseParticipants will perform 8-weeks of moderate intensity endurance (cycling) exercise |
| Resistance Exercise | Experimental | Behavioral: Resistance exerciseParticipants will perform 8-weeks of whole-body resistance exercise training. |
| Control / Combined Training | Experimental | Behavioral: Control/Combined trainingParticipants will perform 8-weeks of no exercise, followed by an additional 8-weeks of combined endurance plus resistance exercise training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- 18 to 30 or >65 years
- Males and Females
Key exclusion criteria (6 listed)
- Regular Exercise Program
- Smoking
- Cardiometabolic Disease (diabetes, cardiovascular disease, thyroid disorders)
- Drugs known to impair metabolic function (beta blockers, steroids)
- Allergies to lidocaine
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 |
|---|---|---|
| Endurance exerciseParticipants will perform 8-weeks of endurance exercise training. Participants will train 5 days per week for 60 min at 65% of VO2 peak. | Behavioural | Endurance Exercise |
| Resistance exerciseParticipants will perform 8-weeks of resistance exercise training. Participants will train 4 days per week for ~60 min. Two days will focus on lower body resistance training and two days will focus on upper body. | Behavioural | Resistance Exercise |
| Control/Combined trainingParticipants will perform 8-weeks of no exercise (control), followed by 8-weeks of combined endurance and resistance training. Participants will endurance train 5 days per week for 30 min at 65% of VO2 peak and resistance train 4 days per week for 30 min. | Behavioural | Control / Combined Training |
Primary outcome
Skeletal Muscle Protein Synthesis
Time frame: Measured at week 0 (baseline) and week 8
The investigators will determine the change from baseline in skeletal muscle protein synthesis. Measurments will be performed at baseline and following 8 weeks of exercise training.
1 secondary outcome
Mitochondrial Function
Time frame: Measured at week 0 (baseline) and week 8
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 12 Dec 2011.
- Derived from this study: PubMed 25599385Irving BA, Lanza IR, Henderson GC, Rao RR, Spiegelman BM, Nair KS. Combined training enhances skeletal muscle mitochondrial oxidative capacity independent of age. J Clin Endocrinol Metab. 2015 Apr;100(4):1654-63. doi: 10.1210/jc.2014-3081. Epub 2015 Jan 19.
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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.
K. Sreekumaran Nair, MD, PD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance exercise and Resistance exercise in people with Sarcopenia, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 6 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 12 Dec 2011. 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 United States. 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?
Skeletal Muscle Protein Synthesis (time frame: Measured at week 0 (baseline) and week 8). 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 NCT01489930, which also lists 1 linked publication.
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 12 Dec 2011.