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Effect of Strength Training and Protein Ingestion in Old Versus Very-old

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ClinicalTrials.gov Identifier: NCT02105922
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : February 28, 2018
Sponsor:
Collaborators:
University of Copenhagen
Arla Foods
Information provided by (Responsible Party):
Lars Holm, Bispebjerg Hospital

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Sarcopenia Muscle Loss Procedure: Heavy Resistance Training Procedure: Light Intensity Training Procedure: Protein Whey Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Strength Training and Protein Ingestion in Old Versus Very-old
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : March 30, 2016
Actual Study Completion Date : March 30, 2016

Arm Intervention/treatment
Active Comparator: Heavy Resistance Training
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.
Procedure: Heavy Resistance Training
Supervised Heavy Resistance Training three times weekly for 3 months.

Experimental: Light Intensity Training
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.
Procedure: Light Intensity Training
Home-based Light Intensity Training three-five times weekly for 3 months.

Active Comparator: Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.
Procedure: Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in quadriceps muscle isometric strength [ Time Frame: Baseline, 3 months ]
    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).

  2. Change in quadriceps muscle isokinetic strength [ Time Frame: Baseline, 3 months ]
    Unilateral knee extension (concentric) strength measured in the KinCom device at an angular velocity of 60 degrees/sec.

  3. Change in leg extension muscle power [ Time Frame: Baseline, 3 months ]
    Unilateral leg extension power measured in the Powerrig device.

  4. Change from baseline in muscle structure and signalling [ Time Frame: Baseline and 3 months ]
    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.

  5. Change in 30 s chair stand [ Time Frame: Baseline, 3 months ]
    Number of stand-ups from a chair in 30 seconds.

  6. Change in whole body composition and bone mineral density [ Time Frame: Baseline, 3 months ]

    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.



Other Outcome Measures:
  1. Change in blood parameters and anthropometry [ Time Frame: Baseline, 3 months ]
    Blood: HbA1c, plasma lipids. Anthropometry: Weight, abdominal circumference. Blood pressure.

  2. Change in gait speed [ Time Frame: Baseline, 3 months ]
    400 m gait speed.

  3. Change in grip strength [ Time Frame: Baseline, 3 months ]
    Isometric hand grip strength.

  4. Questionnaires and interviews [ Time Frame: Baseline, 3 months ]
    Short Form 36

  5. Change in habitual activity [ Time Frame: Baseline, 3 months ]
    Evaluated by 4 days continuous monitoring by a pedometer device (ActivPal).

  6. Change in daily macronutrient intake [ Time Frame: Baseline, 1,5 months ]
    4-days self-report of food and beverage intake.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, independently living
  • Age at least 65 years

Exclusion Criteria:

  • 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.

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): NCT02105922


Locations
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Denmark
Bispbebjerg Hospital
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
University of Copenhagen
Arla Foods
Investigators
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Principal Investigator: Rasmus Bechshøft, Ph.d. Bispebjerg Hospital
Principal Investigator: Lars Holm, Assoc. prof. Bispebjerg Hospital
Principal Investigator: Michael Kjær, MD, Proff. Bispebjerg Hospital
Principal Investigator: Søren Reitelseder, Ph.d. Bispebjerg Hospital
Principal Investigator: Jacob Bülow, MD PhD stud Bispebjerg Hospital

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Responsible Party: Lars Holm, Ph.D. M.S., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02105922     History of Changes
Other Study ID Numbers: H-4-2013-070.2
H-4-2013-070 ( Other Identifier: The Danish National Committee on Biomedical Research Ethics )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes, full data set will be available online.
Keywords provided by Lars Holm, Bispebjerg Hospital:
Frailty
Ageing
Protein supplementation
Protein quality
Exercise training
Sarcopenia
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms