- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03723902
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
Status
Fullført
Forhold
Intervensjon / Behandling
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
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-
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Oslo, Norge, 0863
- Norwegian School of Sport Sciences
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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 |
|---|---|
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Ingen inngripen: Styre
Ingen inngrep
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Eksperimentell: Strength training + protein supplement
Heavy-load strength training, Protein supplementation
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Three weekly sessions of heavy-load strength training for 10 weeks
Andre navn:
Daily supplementation of 2 x 17 grams of milk protein
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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)
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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)
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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
|
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Bone mineral density
Tidsramme: Change from baseline at 10 weeks
|
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
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Change from baseline at 10 weeks
|
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m. Rectus Femoris thickness
Tidsramme: Change from baseline at 10 weeks
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Measured by ultrasound
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Change from baseline at 10 weeks
|
|
m. Vastus Intermedius thickness
Tidsramme: Change from baseline at 10 weeks
|
Measured by ultrasound
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Change from baseline at 10 weeks
|
|
m. Vastus Medialis thickness
Tidsramme: Change from baseline at 10 weeks
|
Measured by ultrasound
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Change from baseline at 10 weeks
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Isometric knee extension rate of force development (RFD max)
Tidsramme: Change from baseline at 10 weeks
|
Measured during maximal voluntary contraction
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Change from baseline at 10 weeks
|
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Isometric knee extension force at 100 ms
Tidsramme: Change from baseline at 10 weeks
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Force at 100 ms during maximal voluntary contraction
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Change from baseline at 10 weeks
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Habitual gait velocity
Tidsramme: Change from baseline at 10 weeks
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Time (sec) to walk 6 meters at preferred gait speed
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Change from baseline at 10 weeks
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Five times chair-rise performance
Tidsramme: Change from baseline at 10 weeks
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Time (sec) to rise from a chair five times
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Change from baseline at 10 weeks
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Stair climbing
Tidsramme: Change from baseline at 10 weeks
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Time (sec) to climb a staircase
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Change from baseline at 10 weeks
|
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Diet assessment
Tidsramme: Change from baseline at 10 weeks
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24-hour diet recall interviews
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Change from baseline at 10 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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
Nøkkelord
Andre studie-ID-numre
- ST-PF
Plan for individuelle deltakerdata (IPD)
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NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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