- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01049698
Improving Muscle for Functional Independence Trial (I'MFIT)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Design Overview:
This is a 5-month randomized trial in 130 older, overweight or obese, sedentary men and women. Phase 1 involves recruitment and screening followed by baseline research testing (Phase 2). Next, subjects will be randomly assigned to one of two 5-month treatments (Phase 3): RT intervention alone (RT) or to an RT with caloric restriction (RT+CR) intervention. Subjects will return for visits the completion of their 5 month intervention. A subset of participants (n=30) will return for an 18 month follow up.
Interventions:
Resistance training+ Caloric Restriction:Participants assigned to RT+CR group will be instructed to follow a hypocaloric diet (-600 kcal/d) for 20 weeks, as well as the resistance training program noted below.In addition, all participants will be provided with a daily calcium (1200 mg/d) and vitamin D (800 IU/d) supplement.The intervention will incorporate meal replacements, nutrition education, and lifestyle behavior modifications.
Resistance training: The maximal weight that can be lifted with correct form in a single repetition (1RM) will be used to prescribe intensity. Strength testing will be repeated every 4 wks and the training loads adjusted so that they are consistent with the 70% 1RM goal. Participants will exercise 3 d/wk on Nautilus resistance machines, under the supervision of two exercise leaders who are trained in basic life support and in emergency management procedures. All exercise will take place at Wake Forest University's Department of Health and Exercise Science Clinical Research Center (CRC). Participants will exercise in small groups which will allow a rotation/rest between machines and enhance the social environment. Heart rate and blood pressure will be measured before and after each session. Subjects will warm-up by walking or cycling for 5 minutes at a slow pace followed by large muscle flexibility exercises. The interventionists will ensure that participants adjust the equipment appropriate to their body size and complete the exercises with correct form. Training sessions will end with a cool-down by walking or cycling for 5 minutes at a slow pace followed by light stretching.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
North Carolina
-
Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest University Health Sciences
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- BMI=27-34.9 kg/m2
- No resistance training for past 6 mos
- Normal cognitive function (MMSE >24)
- No contraindications for participation in weight loss or resistance exercise including severe arthritis or musculoskeletal disorders, knee or hip replacement or spinal surgery in past year
- No broken bones in the past 6 months
- Able to provide own transportation to study visits and intervention
- Not involved in any other research study and not undergoing physical therapy
- Not dependent on a cane or walker
Exclusion Criteria:
- Weight loss or gain (±5%) in past 6 months
- Body mass >136 kg (DXA limit)
- Current smoker (No nicotine within past year) or evidence of alcohol or drug abuse
- Insulin dependent or uncontrolled diabetes (FBG >140 mg/dL)
- Uncontrolled hypertension (BP>180/100 mmHg)
- Abnormal kidney function or liver blood tests
- Past or current cardiovascular disease, including uncontrolled angina or dysrhythmia, hypertrophic cardiomyopathy, congestive heart failure, PAD, stroke, history of myocardial infarction, use of defibrillator or major heart surgery, or deep vein thrombosis or pulmonary embolus
- Past or current respiratory disease (requiring steroid treatment or supplemental oxygen)
- Past or current clinical diagnoses of neurological or hematological disease
- Use of any medications that could influence study variables (growth/steroid hormones, prescription anti-inflammatory medications, or beta blockers, Coumadin or any other blood thinner, including Plavix, Ticid, and Aggrenox)
- Cancer requiring treatment in past 2 years, except non-melanoma skin cancers
- Clinically evident edema or anemia
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: 1. Resistance Training
3 d/wk resistance training
|
3 d/wk resistance training
Altri nomi:
|
Sperimentale: 2. Resistance Training + Diet
Resistance training plus caloric restriction
|
3 d/w resistance training plus 600 kcal/d deficit
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Skeletal muscle function (muscle quality and muscle power) and overall physical function (SPPB score)
Lasso di tempo: 5 month study with baseline and 5 and 18 month follow up assessment visits
|
5 month study with baseline and 5 and 18 month follow up assessment visits
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
single-fiber contractile force and power, intramyocellular lipid (IMCL), muscle gene and protein expression of interleukin-6 (IL-6) and tumor necrosis factor alpha.
Lasso di tempo: baseline and 5 and 18-month follow-up
|
baseline and 5 and 18-month follow-up
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Barbara J Nicklas, PhD, Wake Forest University Health Sciences
Pubblicazioni e link utili
Pubblicazioni generali
- Bharadwaj MS, Tyrrell DJ, Leng I, Demons JL, Lyles MF, Carr JJ, Nicklas BJ, Molina AJ. Relationships between mitochondrial content and bioenergetics with obesity, body composition and fat distribution in healthy older adults. BMC Obes. 2015 Oct 6;2:40. doi: 10.1186/s40608-015-0070-4. eCollection 2015.
- Jefferson ME, Nicklas BJ, Chmelo EA, Crotts CI, Shaltout HA, Diz DI, Marsh AP, Brinkley TE. Effects of Resistance Training With and Without Caloric Restriction on Arterial Stiffness in Overweight and Obese Older Adults. Am J Hypertens. 2016 Apr;29(4):494-500. doi: 10.1093/ajh/hpv139. Epub 2015 Aug 20.
- Nicklas BJ, Chmelo E, Delbono O, Carr JJ, Lyles MF, Marsh AP. Effects of resistance training with and without caloric restriction on physical function and mobility in overweight and obese older adults: a randomized controlled trial. Am J Clin Nutr. 2015 May;101(5):991-9. doi: 10.3945/ajcn.114.105270. Epub 2015 Mar 11.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB00009098
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Resistance Training
-
Stanford UniversityCompletatoSindrome da deficit di attenzione e iperattivitàStati Uniti
-
Nottingham University Hospitals NHS TrustCompletato
-
Gallaudet UniversityDepartment of Health and Human ServicesReclutamentoPerdita dell'udito | SorditàStati Uniti
-
KTO Karatay UniversityCompletatoIctus | Riabilitazione dell'ictusTacchino
-
University of Maryland, College ParkNational Institutes of Health (NIH); National Institute on Aging (NIA)ReclutamentoDisturbi percettivi uditivi | Problemi di invecchiamentoStati Uniti
-
Institut d'Investigació Biomèdica de Girona Dr....Attivo, non reclutanteRiabilitazione | Infezione respiratoria da COVID-19 | FisioterapistiSpagna
-
AccareCompletatoSintomi comportamentali | Comportamento problema | ADHD | Problema di comportamento del bambino | ADHD Tipo prevalentemente disattento | ADHD - Tipo combinato | Problema di comportamento | Comportamento dirompente | Problema comportamentale | ADHD, tipo prevalentemente iperattivo-impulsivoOlanda
-
Université de MontréalFonds de la Recherche en Santé du QuébecCompletato
-
Chang Gung UniversityCompletato
-
Jacobs University Bremen gGmbHGoethe University; University Hospital Ulm; Techniker Krankenkasse; German Coalition... e altri collaboratoriCompletatoCorrelati alla gravidanzaGermania