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

Primary Purpose

Sarcopenia, Muscle Loss

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Heavy Resistance Training

Light Intensity Training

Protein Whey

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Frailty, Ageing, Protein supplementation, Protein quality, Exercise training, Sarcopenia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Bispbebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Heavy Resistance Training

Light Intensity Training

Protein Whey

Arm Description

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.

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.

Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Change in quadriceps muscle isokinetic strength

Unilateral knee extension (concentric) strength measured in the KinCom device at an angular velocity of 60 degrees/sec.

Change in leg extension muscle power

Unilateral leg extension power measured in the Powerrig device.

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.

Change in 30 s chair stand

Number of stand-ups from a chair in 30 seconds.

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.

Full Information

NCT ID

NCT02105922

First Posted

April 3, 2014

Last Updated

February 26, 2018

Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen, Arla Foods

1. Study Identification

Unique Protocol Identification Number

NCT02105922

Brief Title

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

April 1, 2014 (Actual)

Primary Completion Date

March 30, 2016 (Actual)

Study Completion Date

March 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen, Arla Foods

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia, Muscle Loss

Keywords

Frailty, Ageing, Protein supplementation, Protein quality, Exercise training, Sarcopenia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Heavy Resistance Training

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Light Intensity Training

Arm Type

Experimental

Arm Description

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.

Arm Title

Protein Whey

Arm Type

Active Comparator

Arm Description

Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.

Intervention Type

Procedure

Intervention Name(s)

Heavy Resistance Training

Intervention Description

Supervised Heavy Resistance Training three times weekly for 3 months.

Intervention Type

Procedure

Intervention Name(s)

Light Intensity Training

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Protein Whey

Intervention Description

Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.

Primary Outcome Measure Information:

Title

Change in muscle cross sectional area

Description

Time Frame

Baseline, 3 months

Secondary Outcome Measure Information:

Title

Change in quadriceps muscle isometric strength

Description

Time Frame

Baseline, 3 months

Title

Change in quadriceps muscle isokinetic strength

Description

Unilateral knee extension (concentric) strength measured in the KinCom device at an angular velocity of 60 degrees/sec.

Time Frame

Baseline, 3 months

Title

Change in leg extension muscle power

Description

Unilateral leg extension power measured in the Powerrig device.

Time Frame

Baseline, 3 months

Title

Change from baseline in muscle structure and signalling

Description

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.

Time Frame

Baseline and 3 months

Title

Change in 30 s chair stand

Description

Number of stand-ups from a chair in 30 seconds.

Time Frame

Baseline, 3 months

Title

Change in whole body composition and bone mineral density

Description

Time Frame

Baseline, 3 months

Other Pre-specified Outcome Measures:

Title

Change in blood parameters and anthropometry

Description

Blood: HbA1c, plasma lipids. Anthropometry: Weight, abdominal circumference. Blood pressure.

Time Frame

Baseline, 3 months

Title

Change in gait speed

Description

400 m gait speed.

Time Frame

Baseline, 3 months

Title

Change in grip strength

Description

Isometric hand grip strength.

Time Frame

Baseline, 3 months

Title

Questionnaires and interviews

Description

Short Form 36

Time Frame

Baseline, 3 months

Title

Change in habitual activity

Description

Evaluated by 4 days continuous monitoring by a pedometer device (ActivPal).

Time Frame

Baseline, 3 months

Title

Change in daily macronutrient intake

Description

4-days self-report of food and beverage intake.

Time Frame

Baseline, 1,5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: