- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03723902
The Effect of Strength Training and Protein Supplementation in Old Pre-frail Individuals
12 mars 2019 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
22
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Oslo, Norge, 0863
- Norwegian School of Sport Sciences
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
75 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Kontrollera
Inget ingripande
|
|
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Experimentell: 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
Andra namn:
Daily supplementation of 2 x 17 grams of milk protein
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Muscle strength of m. Quadriceps Femoris
Tidsram: 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
Tidsram: 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
Tidsram: Change from baseline at 10 weeks
|
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
|
Change from baseline at 10 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
m. Vastus Lateralis tjocklek
Tidsram: Ändring från baslinjen vid 10 veckor
|
Mäts med ultraljud
|
Ändring från baslinjen vid 10 veckor
|
|
Total lean mass
Tidsram: Change from baseline at 10 weeks
|
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
|
Change from baseline at 10 weeks
|
|
Fat mass
Tidsram: Change from baseline at 10 weeks
|
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
|
Change from baseline at 10 weeks
|
|
Bone mineral density
Tidsram: 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
Tidsram: Change from baseline at 10 weeks
|
Measured by ultrasound
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Change from baseline at 10 weeks
|
|
m. Vastus Intermedius thickness
Tidsram: Change from baseline at 10 weeks
|
Measured by ultrasound
|
Change from baseline at 10 weeks
|
|
m. Vastus Medialis thickness
Tidsram: Change from baseline at 10 weeks
|
Measured by ultrasound
|
Change from baseline at 10 weeks
|
|
Isometric knee extension rate of force development (RFD max)
Tidsram: Change from baseline at 10 weeks
|
Measured during maximal voluntary contraction
|
Change from baseline at 10 weeks
|
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Isometric knee extension force at 100 ms
Tidsram: Change from baseline at 10 weeks
|
Force at 100 ms during maximal voluntary contraction
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Change from baseline at 10 weeks
|
|
Habitual gait velocity
Tidsram: Change from baseline at 10 weeks
|
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
Tidsram: Change from baseline at 10 weeks
|
Time (sec) to rise from a chair five times
|
Change from baseline at 10 weeks
|
|
Stair climbing
Tidsram: Change from baseline at 10 weeks
|
Time (sec) to climb a staircase
|
Change from baseline at 10 weeks
|
|
Diet assessment
Tidsram: Change from baseline at 10 weeks
|
24-hour diet recall interviews
|
Change from baseline at 10 weeks
|
Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2015
Primärt slutförande (Faktisk)
21 december 2015
Avslutad studie (Faktisk)
21 december 2015
Studieregistreringsdatum
Först inskickad
26 oktober 2018
Först inskickad som uppfyllde QC-kriterierna
29 oktober 2018
Första postat (Faktisk)
30 oktober 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 mars 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 mars 2019
Senast verifierad
1 mars 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- ST-PF
Plan för individuella deltagardata (IPD)
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NEJ
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