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

NCT02105922 | Completed DMC

• 2 other identifiers: H-4-2013-070.2H-4-2013-070
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Muscle Loss

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in quadriceps muscle isometric strength

  Baseline, 3 months

• Change in quadriceps muscle isokinetic strength

  Baseline, 3 months

• Change in leg extension muscle power

  Baseline, 3 months

• Change from baseline in muscle structure and signalling

  Baseline and 3 months

• Change in 30 s chair stand

  Baseline, 3 months

Other Outcomes (6)

• Change in blood parameters and anthropometry

  Baseline, 3 months

• Change in gait speed

  Baseline, 3 months

• Change in grip strength

  Baseline, 3 months

Study Arms (3)

Heavy Resistance Training

ACTIVE COMPARATOR

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

Light Intensity Training

EXPERIMENTAL

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

Protein Whey

ACTIVE COMPARATOR

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

Procedure: Protein Whey

Interventions

Heavy Resistance Training PROCEDURE

Supervised Heavy Resistance Training three times weekly for 3 months.

Heavy Resistance Training

Light Intensity Training PROCEDURE

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

Light Intensity Training

Protein Whey PROCEDURE

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

Protein Whey

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy, independently living
• Age at least 65 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Copenhagen: collaborator
• Arla Foods: collaborator

Study Sites (1)

Bispbebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy; Frailty

Interventions

Whey

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. M.S.

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 7, 2014
• Study Start: April 1, 2014
• Primary Completion: March 30, 2016
• Study Completion: March 30, 2016
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)