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

Ageing Clinical Trial

— 83+  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997320
• Other study ID #: H-4-2013-068
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: October 9, 2015
• Start date: November 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 83 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ageing

Intervention

Other:
• Heavy resistance exercise and nutrition
Heavy resistance exercise of the lower extremities three times weekly for 12 weeks.
• Nutrition supplement
Two daily administrations of nutrient supplementation, each containing 20g of milk protein.

Locations

Country	Name	City	State
Denmark	Institute of Sports Medicine Copenhagen, Bispbebjerg Hospital	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in gait speed from baseline to 3 months	Gait speed averaged over 10m including acceleration. Gait speed averaged over 8m excluding acceleration.	0 and 3 months	No
Other	Change in DEMMI from baseline to 3 months	DeMorton Mobility Index	0 and 3 months	No
Other	Change in 30s chair-stand from baseline to 3 months	30s chair-stand	0 and 3 months	No
Other	Change in Short Form-36 questionnaire from baseline to 3 months		0 and 3 months	No
Other	Change in patella tendon stiffness from baseline to 3 months	Stress-deformation of dominant patella tendon using ultrasound.	0 and 3 months	No
Other	Change in muscle biopsy from baseline to 3 months	Measurements of fiber types, size, capillary density, satellite cell count, mRNA-targets, western blotting, muscular collagen content and distribution.	0 and 3 months	No
Other	Change in standard health parameters from baseline to 3 months	Blood pressure, plasma lipids, HbA1c, anthropometry	0 and 3 months	No
Primary	Change in quadriceps muscle cross sectional area from baseline to 3 months	Assessed by MRI scanning of dominant thigh. 8 slices, each of 1cm thickness, separated by 5cm.	0 and 3 months	No
Secondary	Change in isometric muscle strength from baseline to 3 months	Unilateral measurement of isometric strength in m. quadriceps femoris using KinCom.	0 and 3 months	No
Secondary	Change in isokinetic muscle strength from baseline to 3 months	Unilateral isokinetic muscle strength at 60 degrees/s of m. quadriceps femoris.	0 and 3 months	No
Secondary	Change in leg power from baseline to 3 months	Using a Powerrig, unilateral leg extension power is determined.	0 and 3 months	No