Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

12. marts 2019 opdateret af: Truls Raastad, Norwegian School of Sport Sciences

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Oslo, Norge, 0863
        • Norwegian School of Sport Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

75 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Ingen indgriben
Eksperimentel: Strength training + protein supplement
Heavy-load strength training, Protein supplementation
Three weekly sessions of heavy-load strength training for 10 weeks
Andre navne:
  • Modstandsøvelse
Daily supplementation of 2 x 17 grams of milk protein

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Muscle strength of m. Quadriceps Femoris
Tidsramme: Change from baseline at 10 weks
Maximal isometric muscle strength of m. quadriceps femoris (maximal voluntary contraction for the knee extensors)
Change from baseline at 10 weks
Muscle strength of m. quadriceps femoris
Tidsramme: Change from baseline at 10 weeks
Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum)
Change from baseline at 10 weeks
Leg lean mass
Tidsramme: Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
m. Vastus Lateralis tykkelse
Tidsramme: Ændring fra baseline ved 10 uger
Målt ved ultralyd
Ændring fra baseline ved 10 uger
Total lean mass
Tidsramme: Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks
Fat mass
Tidsramme: Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks
Bone mineral density
Tidsramme: Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks
m. Rectus Femoris thickness
Tidsramme: Change from baseline at 10 weeks
Measured by ultrasound
Change from baseline at 10 weeks
m. Vastus Intermedius thickness
Tidsramme: Change from baseline at 10 weeks
Measured by ultrasound
Change from baseline at 10 weeks
m. Vastus Medialis thickness
Tidsramme: Change from baseline at 10 weeks
Measured by ultrasound
Change from baseline at 10 weeks
Isometric knee extension rate of force development (RFD max)
Tidsramme: Change from baseline at 10 weeks
Measured during maximal voluntary contraction
Change from baseline at 10 weeks
Isometric knee extension force at 100 ms
Tidsramme: Change from baseline at 10 weeks
Force at 100 ms during maximal voluntary contraction
Change from baseline at 10 weeks
Habitual gait velocity
Tidsramme: Change from baseline at 10 weeks
Time (sec) to walk 6 meters at preferred gait speed
Change from baseline at 10 weeks
Five times chair-rise performance
Tidsramme: Change from baseline at 10 weeks
Time (sec) to rise from a chair five times
Change from baseline at 10 weeks
Stair climbing
Tidsramme: Change from baseline at 10 weeks
Time (sec) to climb a staircase
Change from baseline at 10 weeks
Diet assessment
Tidsramme: Change from baseline at 10 weeks
24-hour diet recall interviews
Change from baseline at 10 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2015

Primær færdiggørelse (Faktiske)

21. december 2015

Studieafslutning (Faktiske)

21. december 2015

Datoer for studieregistrering

Først indsendt

26. oktober 2018

Først indsendt, der opfyldte QC-kriterier

29. oktober 2018

Først opslået (Faktiske)

30. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ST-PF

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Heavy-load strength training

Abonner