- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03723902
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
Intervention / Behandling
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:
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
Nøgleord
Andre undersøgelses-id-numre
- ST-PF
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med Heavy-load strength training
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Milton S. Hershey Medical CenterAktiv, ikke rekrutterendeMobilitetsbegrænsning | Gå, besværForenede Stater
-
University of Texas at AustinPOM Wonderful LLCAfsluttetSarkopeni | Kardiovaskulær risikofaktorForenede Stater
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Atlas UniversityAfsluttet
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University of FloridaNational Institute of General Medical Sciences (NIGMS)Afsluttet