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

12. mars 2019 oppdatert av: 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.

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

22

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

75 år og eldre (Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Styre
Ingen inngrep
Eksperimentell: Strength training + protein supplement
Heavy-load strength training, Protein supplementation
Three weekly sessions of heavy-load strength training for 10 weeks
Andre navn:
  • Motstandsøvelse
Daily supplementation of 2 x 17 grams of milk protein

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
m. Vastus Lateralis tykkelse
Tidsramme: Endring fra baseline ved 10 uker
Målt med ultralyd
Endring fra baseline ved 10 uker
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

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2015

Primær fullføring (Faktiske)

21. desember 2015

Studiet fullført (Faktiske)

21. desember 2015

Datoer for studieregistrering

Først innsendt

26. oktober 2018

Først innsendt som oppfylte QC-kriteriene

29. oktober 2018

Først lagt ut (Faktiske)

30. oktober 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • ST-PF

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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