We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Strength Training and Protein Supplementation on Muscles in the Very-old (83+)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01997320
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Rasmus Leidersdorff Bechshøft, Bispebjerg Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Primary hypothesis is that the group conducting exercise improves muscle size, structure and function.


Condition or disease Intervention/treatment Phase
Ageing Other: Heavy resistance exercise and nutrition Other: Nutrition supplement Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effect of Strength Training and Protein Supplementation on the Muscle Function in Very Old Nursinghome Residents
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Other: Heavy resistance exercise and nutrition
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.
 Other: Nutrition supplement
Two daily administrations of nutrient supplementation, each containing 20g of milk protein.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in leg power from baseline to 3 months [ Time Frame: 0 and 3 months ]
    Using a Powerrig, unilateral leg extension power is determined.


Other Outcome Measures:
  1. 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.

  2. Change in DEMMI from baseline to 3 months [ Time Frame: 0 and 3 months ]
    DeMorton Mobility Index

  3. Change in 30s chair-stand from baseline to 3 months [ Time Frame: 0 and 3 months ]
    30s chair-stand

  4. Change in Short Form-36 questionnaire from baseline to 3 months [ Time Frame: 0 and 3 months ]
  5. Change in patella tendon stiffness from baseline to 3 months [ Time Frame: 0 and 3 months ]
    Stress-deformation of dominant patella tendon using ultrasound.

  6. 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.

  7. Change in standard health parameters from baseline to 3 months [ Time Frame: 0 and 3 months ]
    Blood pressure, plasma lipids, HbA1c, anthropometry


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   83 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997320


Locations
Layout table for location information
Denmark
Institute of Sports Medicine Copenhagen, Bispbebjerg Hospital
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Layout table for investigator information
Study Chair: Michael Kjaer, MD, Proff. Head of department
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rasmus Leidersdorff Bechshøft, M.D., Ph.d. student, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01997320    
Other Study ID Numbers: H-4-2013-068
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Keywords provided by Rasmus Leidersdorff Bechshøft, Bispebjerg Hospital:
Sarcopenia
Frailty
Strength
Protein supplementation
Ageing