Ageing83+NCT01997320
Effect of Strength Training and Protein Supplementation on Muscles in the Very-old
A study testing Heavy resistance exercise and nutrition and Nutrition supplement in people with Ageing, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Three months intervention study, investigating the effect of nutrient supplementation (including 20g of milk protein) twice daily with or without additional heavy resistance exercise three times weekly on muscle size, structure and function in 30 subjects at least 83 years of age. Read more about this study
- Who is it for?
- Ages 83 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ageing
- What is being tested?
- Heavy resistance exercise and nutrition and Nutrition supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Oct 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 83 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age at least 83 years
Who cannot join
- Acute severe medical or surgical illnesses.
- Unstable chronic diseases, eg. renal failure, uncontrolled cardiac arrythmias, severe COPD (Chronic Obstructive Pulmonary Disease), diabetes mellitus.
- Bilateral knee alloplastics
- Metal devices compromising MR-scanning.
- Medicine: Anticoagulants (K-vitamin antagonists, heparins, ADP-receptor blockers, direct thrombin inhibitors, factor Xa inhibitors), systemic steroid treatment.
- Dementia
- Regular heavy load resistance exercise more than 20 min/week.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen, Bispbebjerg Hospital
Copenhagen NV, Denmark, 2400
About this study
Official title: Effect of Strength Training and Protein Supplementation on the Muscle Function in Very Old Nursinghome Residents
Three months intervention study, investigating the effect of nutrient supplementation (including 20g of milk protein) twice daily with or without additional heavy resistance exercise three times weekly on muscle size, structure and function in 30 subjects at least 83 years of age.
Primary hypothesis is that the group conducting exercise improves muscle size, structure and function.
Read the detailed description
A total of 30 subjects at least 83 years of age are recruited using advertisements in newspapers, magazines, public places and further personal contact. After information and written ethical consent (in accordance with the Declaration of Helsinki II) health status is evaluated by a medical doctor including blood screening, screening for dementia and routine objective evaluation. If there is no reason to exclude subjects (see exclusion criteria), they are whole-body DXA-scanned (Dual X-ray Absorptiometry) and MR-scanned (Magnetic resonance imaging)(dominant knee and femur) and functional measures (30s chair-stand, 10m and 8m gait speed, DEMMI-test) and strength measures (isometric and isokinetic leg power, power rig, grip strength) and tendon stiffness are measured. At least 4 days after this the first muscle biopsy in the dominant m. vastus lateralis is taken. Hereafter subjects are randomized to one of two groups:
Group one (n=15) is the exercise and nutrition group (HRT). Subjects in this group are to conduct supervised center-based heavy resistance exercise of the lower extremities three times weekly for 12 weeks. As for group two, this group receives nutritional supplementation twice daily throughout the 12 weeks period. Supplementation contains 20g of milk protein and some carbohydrate and lipids.
Group two (n=15) is the nutrition group (PRO). Subjects in this group only receives nutritional supplementation as described above.
After 12 weeks of intervention the same strength- and functional measures are made, DXA- and MR-scans and a second biopsy is made along with tendon stiffness measurement.
Data is collected and analyzed by staff blinded to randomization. Personal data is locked up, and only anonymized data is analyzed. Differences in both primary (m. quadriceps femoris cross sectional area) and secondary outcomes (functional measures, strength measures, muscle cell- and fiber type count, mRNA expression, muscle collagen content and distribution) are evaluated using two-way anova with repeated measures and, if allowed, post-hoc tests. Analysis will be made as intention-to-treat.
Power:
With an expected 10% increase in quadriceps CSA (cross-sectional area) (from 4500 square mm at baseline) with a SD of 600 square mm, power is 82% with alfa 0.05 with inclusion of 15 subjects in each group.
In case of systematic health-issues in response to the intervention, the trial will end immediately.
- Conditions
- Ageing
- Being tested
- Heavy resistance exercise and nutrition, Nutrition supplement
- Keywords
- Sarcopenia, Frailty, Strength, Protein supplementation, Ageing
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy resistance exercise and nutritionOther
Heavy resistance exercise of the lower extremities three times weekly for 12 weeks.
Nutrition supplementOther
Two daily administrations of nutrient supplementation, each containing 20g of milk protein.
| Study group | Role | What they receive |
|---|---|---|
| Heavy resistance exercise and nutrition | Experimental | Heavy resistance exercise of the lower extremities three times weekly for 12 weeks combined with nutrient supplementation twice daily each containing 20g of milk protein. Receives: Other: Heavy resistance exercise and nutrition |
| Nutrition supplement | Active comparator | Nutrient supplementation twice daily for 12 weeks. Each supplement contains 20g of milk protein. Receives: Other: Nutrition supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quadriceps muscle cross sectional area from baseline to 3 months
Assessed by MRI scanning of dominant thigh. 8 slices, each of 1cm thickness, separated by 5cm.
Measured: 0 and 3 months
Secondary outcomes (3)
Change in isometric muscle strength from baseline to 3 months
Unilateral measurement of isometric strength in m. quadriceps femoris using KinCom.
Measured: 0 and 3 months
Change in isokinetic muscle strength from baseline to 3 months
Unilateral isokinetic muscle strength at 60 degrees/s of m. quadriceps femoris.
Measured: 0 and 3 months
Change in leg power from baseline to 3 months
Using a Powerrig, unilateral leg extension power is determined.
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Leidersdorff Bechshøft, Bispebjerg Hospital
- Investigators
- Michael Kjaer, MD, Proff., Study chair, Head of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997320
- Sponsor's protocol ID
- H-4-2013-068
- Acronym
- 83+
- Status last verified
- Oct 2015
- First submitted
- 11 Nov 2013
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength Training and Protein Supplementation on the Muscle Function in Very Old Nursinghome Residents
- ClinicalTrials.gov ID
- NCT01997320
- Acronym / sponsor ID
- 83+ / H-4-2013-068
- Conditions
- Ageing
- Keywords
- Sarcopenia, Frailty, Strength, Protein supplementation, Ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Nov 2013 (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.
Three months intervention study, investigating the effect of nutrient supplementation (including 20g of milk protein) twice daily with or without additional heavy resistance exercise three times weekly on muscle size, structure and function in 30 subjects at least 83 years of age.
Primary hypothesis is that the group conducting exercise improves muscle size, structure and function.
Detailed description
A total of 30 subjects at least 83 years of age are recruited using advertisements in newspapers, magazines, public places and further personal contact. After information and written ethical consent (in accordance with the Declaration of Helsinki II) health status is evaluated by a medical doctor including blood screening, screening for dementia and routine objective evaluation. If there is no reason to exclude subjects (see exclusion criteria), they are whole-body DXA-scanned (Dual X-ray Absorptiometry) and MR-scanned (Magnetic resonance imaging)(dominant knee and femur) and functional measures (30s chair-stand, 10m and 8m gait speed, DEMMI-test) and strength measures (isometric and isokinetic leg power, power rig, grip strength) and tendon stiffness are measured. At least 4 days after this the first muscle biopsy in the dominant m. vastus lateralis is taken. Hereafter subjects are randomized to one of two groups:
Group one (n=15) is the exercise and nutrition group (HRT). Subjects in this group are to conduct supervised center-based heavy resistance exercise of the lower extremities three times weekly for 12 weeks. As for group two, this group receives nutritional supplementation twice daily throughout the 12 weeks period. Supplementation contains 20g of milk protein and some carbohydrate and lipids.
Group two (n=15) is the nutrition group (PRO). Subjects in this group only receives nutritional supplementation as described above.
After 12 weeks of intervention the same strength- and functional measures are made, DXA- and MR-scans and a second biopsy is made along with tendon stiffness measurement.
Data is collected and analyzed by staff blinded to randomization. Personal data is locked up, and only anonymized data is analyzed. Differences in both primary (m. quadriceps femoris cross sectional area) and secondary outcomes (functional measures, strength measures, muscle cell- and fiber type count, mRNA expression, muscle collagen content and distribution) are evaluated using two-way anova with repeated measures and, if allowed, post-hoc tests. Analysis will be made as intention-to-treat.
Power:
With an expected 10% increase in quadriceps CSA (cross-sectional area) (from 4500 square mm at baseline) with a SD of 600 square mm, power is 82% with alfa 0.05 with inclusion of 15 subjects in each group.
In case of systematic health-issues in response to the intervention, the trial will end immediately.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy resistance exercise and nutrition | Experimental | Other: Heavy resistance exercise and nutritionHeavy resistance exercise of the lower extremities three times weekly for 12 weeks combined with nutrient supplementation twice daily each containing 20g of milk protein. |
| Nutrition supplement | Active comparator | Other: Nutrition supplementNutrient supplementation twice daily for 12 weeks. Each supplement contains 20g of milk protein. |
Who may qualify
- Ages
- 83 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age at least 83 years
Key exclusion criteria (7 listed)
- Acute severe medical or surgical illnesses.
- Unstable chronic diseases, eg. renal failure, uncontrolled cardiac arrythmias, severe COPD (Chronic Obstructive Pulmonary Disease), diabetes mellitus.
- Bilateral knee alloplastics
- Metal devices compromising MR-scanning.
- Medicine: Anticoagulants (K-vitamin antagonists, heparins, ADP-receptor blockers, direct thrombin inhibitors, factor Xa inhibitors), systemic steroid treatment.
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 exercise and nutritionHeavy resistance exercise of the lower extremities three times weekly for 12 weeks. | Other | Heavy resistance exercise and nutrition |
| Nutrition supplementTwo daily administrations of nutrient supplementation, each containing 20g of milk protein. | Other | Nutrition supplement |
Primary outcome
Change in quadriceps muscle cross sectional area from baseline to 3 months
Time frame: 0 and 3 months
Assessed by MRI scanning of dominant thigh. 8 slices, each of 1cm thickness, separated by 5cm.
3 secondary outcomes
Change in isometric muscle strength from baseline to 3 months
Time frame: 0 and 3 months
Change in isokinetic muscle strength from baseline to 3 months
Time frame: 0 and 3 months
Change in leg power from baseline to 3 months
Time frame: 0 and 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 12 Oct 2015.
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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.
Michael Kjaer, MD, Proff. study chair
Head of department
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 exercise and nutrition and Nutrition supplement in people with Ageing, 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 1 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 12 Oct 2015. 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 quadriceps muscle cross sectional area from baseline to 3 months (time frame: 0 and 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 12 Oct 2015.