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Trial record 5 of 10364 for:    strength

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

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ClinicalTrials.gov Identifier: NCT03723902
Recruitment Status : Completed
First Posted : October 30, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Truls Raastad, Norwegian School of Sport Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Aging Other: Heavy-load strength training Dietary Supplement: Protein supplementation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Strength Training and Protein Supplementation in Pre-frail Elderly Individuals. Effects on Muscle Mass, Muscle Strength, Rate of Force Development and Functional Capacity
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : December 21, 2015
Actual Study Completion Date : December 21, 2015

Arm Intervention/treatment
Experimental: Strength training + protein supplement
Heavy-load strength training, Protein supplementation
Other: Heavy-load strength training
Three weekly sessions of heavy-load strength training for 10 weeks
Other Name: Resistance exercise

Dietary Supplement: Protein supplementation
Daily supplementation of 2 x 17 grams of milk protein

No Intervention: Control
No intervention



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723902


Locations
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Norway
Norwegian School of Sport Sciences
Oslo, Norway, 0863
Sponsors and Collaborators
Norwegian School of Sport Sciences
Investigators
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Principal Investigator: Truls Raastad, Prof. Norwegian School of Sport Sciences

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Responsible Party: Truls Raastad, Professor, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier: NCT03723902     History of Changes
Other Study ID Numbers: ST-PF
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Truls Raastad, Norwegian School of Sport Sciences:
Strength training
Pre-frail