Skip to main content
OpenTrials
Completed

NCT Number: NCT03723902

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian School of Sport Sciences

Oslo, 0863, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Heavy-load strength training

Other

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

Other names: Resistance exercise

Protein supplementation

Dietary Supplement

Daily supplementation of 2 x 17 grams of milk protein

Primary outcomes

  1. Muscle strength of m. Quadriceps Femoris

    Time frame: Change from baseline at 10 weks

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

  2. Muscle strength of m. quadriceps femoris

    Time frame: Change from baseline at 10 weeks

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

  3. Leg lean mass

    Time frame: Change from baseline at 10 weeks

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

Secondary outcomes

  1. Total lean mass

    Time frame: Change from baseline at 10 weeks

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

  2. Fat mass

    Time frame: Change from baseline at 10 weeks

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

  3. Bone mineral density

    Time frame: Change from baseline at 10 weeks

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

  4. m. Vastus Lateralis thickness

    Time frame: Change from baseline at 10 weeks

    Measured by ultrasound

  5. m. Rectus Femoris thickness

    Time frame: Change from baseline at 10 weeks

    Measured by ultrasound

  6. m. Vastus Intermedius thickness

    Time frame: Change from baseline at 10 weeks

    Measured by ultrasound

  7. m. Vastus Medialis thickness

    Time frame: Change from baseline at 10 weeks

    Measured by ultrasound

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

    Time frame: Change from baseline at 10 weeks

    Measured during maximal voluntary contraction

  9. Isometric knee extension force at 100 ms

    Time frame: Change from baseline at 10 weeks

    Force at 100 ms during maximal voluntary contraction

  10. Habitual gait velocity

    Time frame: Change from baseline at 10 weeks

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

  11. Five times chair-rise performance

    Time frame: Change from baseline at 10 weeks

    Time (sec) to rise from a chair five times

  12. Stair climbing

    Time frame: Change from baseline at 10 weeks

    Time (sec) to climb a staircase

  13. Diet assessment

    Time frame: Change from baseline at 10 weeks

    24-hour diet recall interviews

Sponsors and collaborators

Lead sponsor

Norwegian School of Sport Sciences

Other

Registry information

Official study title

Strength Training and Protein Supplementation in Pre-frail Elderly Individuals. Effects on Muscle Mass, Muscle Strength, Rate of Force Development and Functional Capacity

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2018
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.