Clinical trial NCT02105922: Effect of Strength Training and Protein Ingestion in Old Versus Very-old
Official title: Effect of Strength Training and Protein Ingestion in Old Versus Very-old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Muscle Loss
Keywords: Frailty
Ageing
Protein supplementation
Protein quality
Exercise training
Sarcopenia
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Arla Foods
First posted: 2014-04-07
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in muscle cross sectional area
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in quadriceps muscle isometric strength
timeFrame: Baseline, 3 months
measure: Change in quadriceps muscle isokinetic strength
timeFrame: Baseline, 3 months
measure: Change in leg extension muscle power
timeFrame: Baseline, 3 months
measure: Change from baseline in muscle structure and signalling
timeFrame: Baseline and 3 months
measure: Change in 30 s chair stand
timeFrame: Baseline, 3 months
measure: Change in whole body composition and bone mineral density
timeFrame: Baseline, 3 months
Other outcomes:
measure: Change in blood parameters and anthropometry
timeFrame: Baseline, 3 months
measure: Change in gait speed
timeFrame: Baseline, 3 months
measure: Change in grip strength
timeFrame: Baseline, 3 months
measure: Questionnaires and interviews
timeFrame: Baseline, 3 months
measure: Change in habitual activity
timeFrame: Baseline, 3 months
measure: Change in daily macronutrient intake
timeFrame: Baseline, 1,5 months
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispbebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Rasmus Bechshøft, Ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Lars Holm, Assoc. prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Michael Kjær, MD, Proff.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Søren Reitelseder, Ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Jacob Bülow, MD PhD stud
role: PRINCIPAL_INVESTIGATOR
References: