CClinicalTrials.gg
CompletedNCT03723902Updated Mar 14, 2019

The Effect of Strength Training and Protein Supplementation in Old Pre-frail Individuals

An interventional study of Heavy-load strength training and Protein supplementation in Aging, sponsored by Norwegian School of Sport Sciences. Completed at 1 site in Norway. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by Norwegian School of Sport Sciences · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jul 2015, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study summary

The aim of this study is to investigate the effects of a lower-body strength training regime combined with protein supplementation in pre-frail elderly individuals. Participants are randomized to a group performing three weekly sessions of heavy-load strength training for 10 weeks and receiving daily protein supplementation, or a non-training, non-supplemented control group. The endpoints are changes in body composition, the relative changes in different compartments of the quadriceps femoris muscles, and the relationships between changes in muscle mass, muscle thickness, strength, and functional capacity. The investigators hypothesize that 10 weeks of heavy load strength training and protein supplementation will elicit improvements in muscle mass, strength, and functional performance. Moreover, it is hypothesized that improvements in strength will correlate with the improvements in functional performance.

Read the detailed description

Aging is accompanied by a loss of muscle mass and strength. Because muscle strength is associated with functional performance in elderly individuals, various tasks of daily living is hampered by the overall decline. The consequence is a vicious circle, where inactivity caused by reduced functional capacity accelerates the loss of muscle mass, strength and physical function. The Short Physical Performance Battery (SPPB) is commonly used to assess functional capacity, where individuals with a score of 10 or less out of maximum 12 may be categorized as pre-frail. Because small-to-moderate limitations in functional status assessed by SPPB is associated with higher odds of losing future mobility, these individuals represent a group of great interest. Strategies to improve functional capacity in this population are therefore important. It is established that heavy-load strength training, alone or in combination with protein supplementation, can improve muscle mass, strength, and function in elderly individuals. However, most studies have focused on healthy older adults, and less is known about the effects of heavy-load strength training in pre-frail elderly individuals. Moreover, the extent to which training-induced gains in muscle mass and size are related to improvements in strength and functional capacity is still poorly understood, because few intervention studies in this population have quantified hypertrophy precisely. Hence, the aim of this study is to investigate the effects of 10 weeks of heavy load strength training, performed three times per week, on muscle mass (DXA scan), muscle thickness (ultrasound), muscle strength (dynamic and isometric), rate of force development, chair rise ability, and gait velocity. Participants are randomized to a group performing three weekly sessions of heavy-load strength training or a control group. In addition, to optimize gains in muscle mass and strength, the strength training group will receive daily protein supplementation throughout the intervention period. The investigators hypothesize that the intervention will improve muscle mass, muscle thickness and strength, and that improvements in muscle strength and rate of force development will be correlated with improvements in functional capacity.

02

Conditions studied

  • Aging

Keywords

  • Strength training
  • Pre-frail
03

In context

Lead sponsor

Norwegian School of Sport Sciences is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age > 75
  • Short Physical Performance Battery (SPPB) score ≤ 10

Exclusion criteria

Exclusion Criteria:

  • Lactose intolerance
  • Milk allergy
  • Diseases or musculoskeletal disorders contraindicating training/testing
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Strength training + protein supplement

    Heavy-load strength training, Protein supplementation

    Other: Heavy-load strength training · Dietary Supplement: Protein supplementation

  • No intervention
    Control

    No intervention

Interventions

  • OtherHeavy-load strength training

    Three weekly sessions of heavy-load strength training for 10 weeks

    Also known as: Resistance exercise

  • Dietary supplementProtein supplementation

    Daily supplementation of 2 x 17 grams of milk protein

06

What researchers measure

Primary outcomes

  1. Muscle strength of m. Quadriceps Femoris

    Maximal isometric muscle strength of m. quadriceps femoris (maximal voluntary contraction for the knee extensors)

    Time frame: Change from baseline at 10 weks

  2. Muscle strength of m. quadriceps femoris

    Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum)

    Time frame: Change from baseline at 10 weeks

  3. Leg lean mass

    Measured by Dual-energy X-ray Absorptiometry (DXA-scan)

    Time frame: Change from baseline at 10 weeks

Secondary outcomes

  1. Total lean mass

    Measured by Dual-energy X-ray Absorptiometry (DXA-scan)

    Time frame: Change from baseline at 10 weeks

  2. Fat mass

    Measured by Dual-energy X-ray Absorptiometry (DXA-scan)

    Time frame: Change from baseline at 10 weeks

  3. Bone mineral density

    Measured by Dual-energy X-ray Absorptiometry (DXA-scan)

    Time frame: Change from baseline at 10 weeks

  4. m. Vastus Lateralis thickness

    Measured by ultrasound

    Time frame: Change from baseline at 10 weeks

  5. m. Rectus Femoris thickness

    Measured by ultrasound

    Time frame: Change from baseline at 10 weeks

  6. m. Vastus Intermedius thickness

    Measured by ultrasound

    Time frame: Change from baseline at 10 weeks

  7. m. Vastus Medialis thickness

    Measured by ultrasound

    Time frame: Change from baseline at 10 weeks

  8. Isometric knee extension rate of force development (RFD max)

    Measured during maximal voluntary contraction

    Time frame: Change from baseline at 10 weeks

  9. Isometric knee extension force at 100 ms

    Force at 100 ms during maximal voluntary contraction

    Time frame: Change from baseline at 10 weeks

  10. Habitual gait velocity

    Time (sec) to walk 6 meters at preferred gait speed

    Time frame: Change from baseline at 10 weeks

  11. Five times chair-rise performance

    Time (sec) to rise from a chair five times

    Time frame: Change from baseline at 10 weeks

  12. Stair climbing

    Time (sec) to climb a staircase

    Time frame: Change from baseline at 10 weeks

  13. Diet assessment

    24-hour diet recall interviews

    Time frame: Change from baseline at 10 weeks

07

Study locations

1 site
  • Norwegian School of Sport Sciences
    Oslo, 0863, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03723902
Lead sponsor
Norwegian School of Sport Sciences
Responsible party
Truls Raastad (Professor, Norwegian School of Sport Sciences) — Principal investigator
First posted
Oct 30, 2018
Start date
Jul 1, 2015
Primary completion
Dec 21, 2015
Completion
Dec 21, 2015
Last update
Mar 14, 2019

Study contacts

Truls Raastad, Prof.
principal investigator · Norwegian School of Sport Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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