- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01997320
Effect of Strength Training and Protein Supplementation on Muscles in the Very-old (83+)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen NV, Denmark, 2400
- Institute of Sports Medicine Copenhagen, Bispbebjerg Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age at least 83 years
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heavy resistance exercise and nutrition
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.
|
Heavy resistance exercise of the lower extremities three times weekly for 12 weeks.
|
Active Comparator: Nutrition supplement
Nutrient supplementation twice daily for 12 weeks.
Each supplement contains 20g of milk protein.
|
Two daily administrations of nutrient supplementation, each containing 20g of milk protein.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0 and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in isometric muscle strength from baseline to 3 months
Time Frame: 0 and 3 months
|
Unilateral measurement of isometric strength in m. quadriceps femoris using KinCom.
|
0 and 3 months
|
Change in isokinetic muscle strength from baseline to 3 months
Time Frame: 0 and 3 months
|
Unilateral isokinetic muscle strength at 60 degrees/s of m. quadriceps femoris.
|
0 and 3 months
|
Change in leg power from baseline to 3 months
Time Frame: 0 and 3 months
|
Using a Powerrig, unilateral leg extension power is determined.
|
0 and 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gait speed from baseline to 3 months
Time Frame: 0 and 3 months
|
Gait speed averaged over 10m including acceleration.
Gait speed averaged over 8m excluding acceleration.
|
0 and 3 months
|
Change in DEMMI from baseline to 3 months
Time Frame: 0 and 3 months
|
DeMorton Mobility Index
|
0 and 3 months
|
Change in 30s chair-stand from baseline to 3 months
Time Frame: 0 and 3 months
|
30s chair-stand
|
0 and 3 months
|
Change in Short Form-36 questionnaire from baseline to 3 months
Time Frame: 0 and 3 months
|
0 and 3 months
|
|
Change in patella tendon stiffness from baseline to 3 months
Time Frame: 0 and 3 months
|
Stress-deformation of dominant patella tendon using ultrasound.
|
0 and 3 months
|
Change in muscle biopsy from baseline to 3 months
Time Frame: 0 and 3 months
|
Measurements of fiber types, size, capillary density, satellite cell count, mRNA-targets, western blotting, muscular collagen content and distribution.
|
0 and 3 months
|
Change in standard health parameters from baseline to 3 months
Time Frame: 0 and 3 months
|
Blood pressure, plasma lipids, HbA1c, anthropometry
|
0 and 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Michael Kjaer, MD, Proff., head of department
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-4-2013-068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ageing
-
Centre Hospitalier Universitaire de NiceRecruiting
-
Lund UniversityThe Swedish Research Council; Linnaeus UniversityCompleted
-
Norwegian University of Science and TechnologyCompleted
-
University of GlasgowCompleted
-
University of SouthamptonNational Institute for Health Research, United KingdomUnknown
-
Assistance Publique - Hôpitaux de ParisUnknown
-
Wageningen UniversityCompleted
-
Quadram Institute BioscienceNorfolk and Norwich University Hospitals NHS Foundation TrustActive, not recruitingAgeingUnited Kingdom
-
University Hospital, LimogesCompleted
-
The University of Hong KongRecruiting
Clinical Trials on Heavy resistance exercise and nutrition
-
Norwegian School of Sport SciencesUniversity of Oslo; Oslo University Hospital; University of Copenhagen; University... and other collaboratorsCompleted
-
Mustafa Kemal UniversityThe Scientific and Technological Research Council of TurkeyNot yet recruitingSubacromial Impingement Syndrome | Bicep Tendinitis | Rotator Cuff TendinopathyTurkey
-
Jamia Millia IslamiaCompleted
-
Allegheny Singer Research Institute (also known...Recruiting
-
Universidade Cidade de Sao PauloTerminatedPatellar TendinopathyBrazil
-
George Washington UniversityUnited States Department of Agriculture (USDA)Completed
-
Norwegian School of Sport SciencesCompleted
-
Uppsala UniversityRigshospitalet, Denmark; University of Agder; Norwegian School of Sport Sciences and other collaboratorsActive, not recruitingBreast Cancer FemaleSweden
-
University of CopenhagenCompleted
-
Bispebjerg HospitalCompletedJumper's Knee | Patellar TendinopathyDenmark