SarcopeniaNCT02105922
Effect of Strength Training and Protein Ingestion in Old Versus Very-old
A study testing Heavy Resistance Training, Light Intensity Training and Protein Whey in people with Sarcopenia and Muscle Loss, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
From 3 interventiongroups in the project with ClinicalTrials.gov ID NCT02034760, namely: HRTW: Heavy Strength Training x3/week \& 20g whey protein twice daily. LITW: Light Intensity Training x3-5/week \& 20g whey protein twice daily. WHEY: 20g whey protein twice daily. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Muscle Loss
- What is being tested?
- Heavy Resistance Training, Light Intensity Training and Protein Whey
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2014to 30 Mar 2016
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy, independently living
- Age at least 65 years
Who cannot join
- Subjects dependent on help/nursing etc.
- Chronic medical diseases: Diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia.
- Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens.
- Implanted magnetic devices incompatible with MRi-scanning.
- Weekly alcohol consumption > 21 units (1 unit equals 4g of ethanol) for men and > 14 for women.
- Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40mg/day or if combined with subjective myalgia, ACE-inhibitors, Angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparing diuretics and loop diuretics.
- >1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation.
Trial locations and contacts
1 site in 1 country.
About this study
From 3 interventiongroups in the project with ClinicalTrials.gov ID NCT02034760, namely:
HRTW: Heavy Strength Training x3/week \& 20g whey protein twice daily. LITW: Light Intensity Training x3-5/week \& 20g whey protein twice daily. WHEY: 20g whey protein twice daily.
15 subjects from each group will be recruited and tested after 3 months of intervention. Tests will include muscle cross sectional area (MRi), muscle biopsies (fiber types, size, cell- and capillary count), functional- and strength measurements, plasma lipids, HbA1c. Tests are to be compared with Project ID NCT01997320.
Read the detailed description
In- and exclusion criteria are listed in NCT02034760. Subjects will be randomized to interventions as described, and 15 subjects from each of the three groups will be tested after 12 weeks of intervention.
15 subjects are included in each group to account for an expected drop-out rate of 20%, and so 12 subjects are expected to complete each intervention. With this N an increase of around 11% in MRi-evaluated muscle size can be detected with a powerlevel of 80% and an alpha of 0.05 and use of reported SD.
Primary outcome is muscle size (MRi), and secondary outcomes are overall body composition (DXA), muscle strength, rate of force development, power, 30s chair stand, 400m gait speed, grip strength. Tertiary outcomes are habitual activitylevel (accelerometry), blood samples (HbA1c, cholesterols, creatinine), blood pressure, weight, BMI, wast- and hip circumference.
Results are to be compared with NCT01997320 and so a population of 65+ can be compared with a population of 83+. Both studies uses the same heavy strength training regimen.
- Conditions
- Sarcopenia, Muscle Loss
- Being tested
- Heavy Resistance Training, Light Intensity Training, Protein Whey
- Keywords
- Frailty, Ageing, Protein supplementation, Protein quality, Exercise training, Sarcopenia
- Medical subject headings
- Sarcopenia, Muscular Atrophy, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy Resistance TrainingProcedure or surgery
Supervised Heavy Resistance Training three times weekly for 3 months.
Light Intensity TrainingProcedure or surgery
Home-based Light Intensity Training three-five times weekly for 3 months.
Protein WheyProcedure or surgery
Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Heavy Resistance Training | Active comparator | Heavy Resistance Training of the lower extremities three times weekly in combination with two daily 20g whey protein and 10g carbohydrate supplementations for 3 months. Receives: Procedure: Heavy Resistance Training |
| Light Intensity Training | Experimental | Home-based Light Intensity Training of the lower extremities three-five times weekly in combination with two daily 20g whey protein and 10g carbohydrate supplementations for 3 months. Receives: Procedure: Light Intensity Training |
| Protein Whey | Active comparator | Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months. Receives: Procedure: Protein Whey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle cross sectional area
MRi scans of quadriceps muscle cross sectional area. The statistical evaluation of the primary outcome measure is done by applying a two way ANOVA test comparing groups: 1) Heavy Resistance Training vs. Light Intensity Training vs. Protein Whey. The statistical evaluation will be performed first as an intension-to-treat analysis and subsequently as a per-protocol analysis.
Measured: Baseline, 3 months
Secondary outcomes (6)
Change in quadriceps muscle isometric strength
Isometric unilateral quadriceps force and rate of force development measured in the isokinetic dynamometer device (KinCom) during knee extension at the knee angle 70 deg (with 0 degrees being fully extended).
Measured: Baseline, 3 months
Change in quadriceps muscle isokinetic strength
Unilateral knee extension (concentric) strength measured in the KinCom device at an angular velocity of 60 degrees/sec.
Measured: Baseline, 3 months
Change in leg extension muscle power
Unilateral leg extension power measured in the Powerrig device.
Measured: Baseline, 3 months
Change from baseline in muscle structure and signalling
From muscle biopsies muscle fiber type distribution and size, capillary density, satellite cell count and activity, selected gene-expression targets and protein concentrations will be assessed.
Measured: Baseline and 3 months
Change in 30 s chair stand
Number of stand-ups from a chair in 30 seconds.
Measured: Baseline, 3 months
Change in whole body composition and bone mineral density
Body composition (fat mass, lean mass and bone mass) evaluated by whole-body dual energy x-ray absorptiometry (DXA)-scanning.
Bone mineral density at dominant collum femoris and vertebrae L2-L4 evaluated by DXA-scanning.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study start1 Apr 2014
- Primary completion30 Mar 2016
- Study completion30 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Arla Foods
- Responsible party
- Principal investigator, Lars Holm, Bispebjerg Hospital
- Investigators
- Rasmus Bechshøft, Ph.d., Principal investigator, Bispebjerg HospitalLars Holm, Assoc. prof., Principal investigator, Bispebjerg HospitalMichael Kjær, MD, Proff., Principal investigator, Bispebjerg HospitalSøren Reitelseder, Ph.d., Principal investigator, Bispebjerg HospitalJacob Bülow, MD PhD stud, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105922
- Sponsor's protocol ID
- H-4-2013-070.2
- Other IDs
- H-4-2013-070
- Status last verified
- Feb 2018
- First submitted
- 3 Apr 2014
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Yes, full data set will be available online.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength Training and Protein Ingestion in Old Versus Very-old
- ClinicalTrials.gov ID
- NCT02105922
- Acronym / sponsor ID
- H-4-2013-070.2
- Conditions
- Sarcopenia, Muscle Loss
- Keywords
- Frailty, Ageing, Protein supplementation, Protein quality, Exercise training, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Arla Foods
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 30 Mar 2016 (actual)
- First posted
- 7 Apr 2014 (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.
From 3 interventiongroups in the project with ClinicalTrials.gov ID NCT02034760, namely:
HRTW: Heavy Strength Training x3/week \& 20g whey protein twice daily. LITW: Light Intensity Training x3-5/week \& 20g whey protein twice daily. WHEY: 20g whey protein twice daily.
15 subjects from each group will be recruited and tested after 3 months of intervention. Tests will include muscle cross sectional area (MRi), muscle biopsies (fiber types, size, cell- and capillary count), functional- and strength measurements, plasma lipids, HbA1c. Tests are to be compared with Project ID NCT01997320.
Detailed description
In- and exclusion criteria are listed in NCT02034760. Subjects will be randomized to interventions as described, and 15 subjects from each of the three groups will be tested after 12 weeks of intervention.
15 subjects are included in each group to account for an expected drop-out rate of 20%, and so 12 subjects are expected to complete each intervention. With this N an increase of around 11% in MRi-evaluated muscle size can be detected with a powerlevel of 80% and an alpha of 0.05 and use of reported SD.
Primary outcome is muscle size (MRi), and secondary outcomes are overall body composition (DXA), muscle strength, rate of force development, power, 30s chair stand, 400m gait speed, grip strength. Tertiary outcomes are habitual activitylevel (accelerometry), blood samples (HbA1c, cholesterols, creatinine), blood pressure, weight, BMI, wast- and hip circumference.
Results are to be compared with NCT01997320 and so a population of 65+ can be compared with a population of 83+. Both studies uses the same heavy strength training regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heavy Resistance Training | Active comparator | Procedure: Heavy Resistance TrainingHeavy Resistance Training of the lower extremities three times weekly in combination with two daily 20g whey protein and 10g carbohydrate supplementations for 3 months. |
| Light Intensity Training | Experimental | Procedure: Light Intensity TrainingHome-based Light Intensity Training of the lower extremities three-five times weekly in combination with two daily 20g whey protein and 10g carbohydrate supplementations for 3 months. |
| Protein Whey | Active comparator | Procedure: Protein WheyTwo daily 20g whey protein and 10g carbohydrate supplementations for 3 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Healthy, independently living
- Age at least 65 years
Key exclusion criteria (7 listed)
- Subjects dependent on help/nursing etc.
- Chronic medical diseases: Diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia.
- Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens.
- Implanted magnetic devices incompatible with MRi-scanning.
- Weekly alcohol consumption > 21 units (1 unit equals 4g of ethanol) for men and > 14 for women.
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 |
|---|---|---|
| Heavy Resistance TrainingSupervised Heavy Resistance Training three times weekly for 3 months. | Procedure or surgery | Heavy Resistance Training |
| Light Intensity TrainingHome-based Light Intensity Training three-five times weekly for 3 months. | Procedure or surgery | Light Intensity Training |
| Protein WheyTwo daily 20g whey protein and 10g carbohydrate supplementations for 3 months. | Procedure or surgery | Protein Whey |
Primary outcome
Change in muscle cross sectional area
Time frame: Baseline, 3 months
MRi scans of quadriceps muscle cross sectional area. The statistical evaluation of the primary outcome measure is done by applying a two way ANOVA test comparing groups: 1) Heavy Resistance Training vs. Light Intensity Training vs. Protein Whey. The statistical evaluation will be performed first as an intension-to-treat analysis and subsequently as a per-protocol analysis.
6 secondary outcomes
Change in quadriceps muscle isometric strength
Time frame: Baseline, 3 months
Change in quadriceps muscle isokinetic strength
Time frame: Baseline, 3 months
Change in leg extension muscle power
Time frame: Baseline, 3 months
Change from baseline in muscle structure and signalling
Time frame: Baseline and 3 months
Change in 30 s chair stand
Time frame: Baseline, 3 months
Change in whole body composition and bone mineral density
Time frame: Baseline, 3 months
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 28 Feb 2018.
- Individual participant dataSharing planned: Yes. Yes, full data set will be available online.
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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.
Rasmus Bechshøft, Ph.d. principal investigator
Bispebjerg Hospital
Lars Holm, Assoc. prof. principal investigator
Bispebjerg Hospital
Michael Kjær, MD, Proff. 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 Heavy Resistance Training, Light Intensity Training and Protein Whey in people with Sarcopenia and Muscle Loss, 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 2 inclusion and 7 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 28 Feb 2018. 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?
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 muscle cross sectional area (time frame: Baseline, 3 months). 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 28 Feb 2018.