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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105922
• Other study ID #: H-4-2013-070.2
• Secondary ID: H-4-2013-070
• Status: Completed
• Phase: N/A
• First received: April 3, 2014
• Last updated: February 26, 2018
• Start date: April 1, 2014
• Est. completion date: March 30, 2016

Study information

• Verified date: February 2018
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 30, 2016
• Est. primary completion date: March 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Loss
• Sarcopenia

Intervention

Procedure:
• Heavy Resistance Training
Supervised Heavy Resistance Training three times weekly for 3 months.
• Light Intensity Training
Home-based Light Intensity Training three-five times weekly for 3 months.
• Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.

Locations

Country	Name	City	State
Denmark	Bispbebjerg Hospital	Copenhagen NV

Sponsors (3)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Arla Foods, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood parameters and anthropometry	Blood: HbA1c, plasma lipids. Anthropometry: Weight, abdominal circumference. Blood pressure.	Baseline, 3 months
Other	Change in gait speed	400 m gait speed.	Baseline, 3 months
Other	Change in grip strength	Isometric hand grip strength.	Baseline, 3 months
Other	Questionnaires and interviews	Short Form 36	Baseline, 3 months
Other	Change in habitual activity	Evaluated by 4 days continuous monitoring by a pedometer device (ActivPal).	Baseline, 3 months
Other	Change in daily macronutrient intake	4-days self-report of food and beverage intake.	Baseline, 1,5 months
Primary	Change in muscle cross sectional area	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.	Baseline, 3 months
Secondary	Change in quadriceps muscle isometric strength	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).	Baseline, 3 months
Secondary	Change in quadriceps muscle isokinetic strength	Unilateral knee extension (concentric) strength measured in the KinCom device at an angular velocity of 60 degrees/sec.	Baseline, 3 months
Secondary	Change in leg extension muscle power	Unilateral leg extension power measured in the Powerrig device.	Baseline, 3 months
Secondary	Change from baseline in muscle structure and signalling	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.	Baseline and 3 months
Secondary	Change in 30 s chair stand	Number of stand-ups from a chair in 30 seconds.	Baseline, 3 months
Secondary	Change in whole body composition and bone mineral density	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.	Baseline, 3 months