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Completed

NCT Number: NCT01997320

Effect of Strength Training and Protein Supplementation on Muscles in the Very-old

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.

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Key information

Age range

83 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Medicine Copenhagen, Bispbebjerg Hospital

Copenhagen NV, Denmark, 2400

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heavy resistance exercise and nutrition

Other

Heavy resistance exercise of the lower extremities three times weekly for 12 weeks.

Nutrition supplement

Other

Two daily administrations of nutrient supplementation, each containing 20g of milk protein.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

Effect of Strength Training and Protein Supplementation on the Muscle Function in Very Old Nursinghome Residents

Acronym: 83+

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Nov 28, 2013
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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