Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy (DPN)
14 gennaio 2022 aggiornato da: Odessa Addison, DPT, PhD, University of Maryland, Baltimore
High Intensity Muscle Power and Balance Perturbation Training to Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy
Type 2 diabetes results in a host of neuromuscular, muscular, and autonomic system impairments that accelerate age-associated limitations in functional independence and the risk of falls.
Diabetic peripheral neuropathy (DPN) contributes to functional declines in balance and mobility because of limitations metabolic abnormalities.
The constellation of impairments accompanying type 2 diabetes diminishes muscle function and performance including strength and power.
Loss of strength at higher speeds of movement (deficit in power) occurs in neural activation of muscles, changes in muscle properties, and through in older individuals with DPN compared to older controls.
Consequently, this deficit in speed dependent muscle power production leads to limitations in rapidly responding to sudden loss of balance stability to prevent falling.
The goal of this pilot research program is to determine the feasibility and effectiveness of a mechanism-based therapeutic intervention fro improving balance and mobility functions and preventing falls in older adults with DPN.
The investigators pan to use the results from this pilot study to design and implement a larger randomized control trial.
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The long-term goal of this research is to establish the effectiveness of a mechanism-based therapeutic intervention for improving balance and mobility functions and preventing falls in older adults with type 2 diabetic peripheral neuropathy (DPN).
Specific Aim 1 will determine if combined high intensity isolated leg muscle power exercise with balance perturbation training (ActiveStep) and aerobic exercise achieves greater improvements in balance stabilization (protective stepping behavior and kinematics) and mobility function (gait parameters and timed functional measures) than a lifestyle based intervention that primarily focuses on aerobic exercise through underlying mechanisms of improved neuromuscular activation (rate and magnitude) and sensorimotor control, improved muscle quality, and increased blood flow to enhance neuromuscular and sensorimotor performance in people with DPN.
Specific Aim #2: To determine if a neuromotor balance training program combined with muscle power exercise training and aerobic exercise, leading to improved neuromuscular and sensorimotor mechanisms, is more effective in improving clinical tests of balance and mobility functions in those with DPN compared with a traditional exercise intervention.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
3
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- VA Maryland Health Care System
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Baltimore, Maryland, Stati Uniti, 21201-1082
- University of Maryland School of Medicine
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 55 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- HbA1C of 5.7% to 9.0% or a fasting blood glucose of greater than or equal to 100
- Participants that are diabetic should be stable on medications for at least 3 months prior to entering the study
- Neuropathy is most likely caused by impaired glucose regulation determined by medical or family history
- Autonomic neuropathy as defined by Toronto Neuropathy Expert Group 2010/2011 consensus criteria
- Medically stable at time of enrollment as determined by screening process
Exclusion Criteria:
- Neuropathy due to factors other than impaired glucose regulation determined by screening process
- Other severe medical illness or condition that would preclude safe participation in the study as determined by the study team
- Severe Autonomic Neuropathy that would limit study participation
- Musculoskeletal limitations that would preclude participation in balance assessment of protective stepping
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Muscle, Balance, and aerobic exercise
This trial will have a single experimental arm that will include the following interventions: Leg muscle strengthening, balance training using balance perturbations, and aerobic exercise.
All individuals in this trial will receive all interventions listed.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months
Lasso di tempo: baseline, 3 months, and 6 months
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A Computed Tomography Scan will be used to measure the cross sectional area of the leg muscles in cm.
Changes from baseline to 3 and 6 months will be examined.
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baseline, 3 months, and 6 months
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Change in leg muscle strength as determined with a physiological test from baseline to 3 months and baseline to 6 months
Lasso di tempo: baseline, 3 months, and 6 months
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A strength testing machine will be used to test the strength of the legs in newton meters.
Changes from baseline to 3 and 6 months will be examined.
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baseline, 3 months, and 6 months
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Change in cardiac autonomic neuropathy as determined by heart rate variability from baseline to 3 months and baseline to 6 months
Lasso di tempo: baseline, 3 months, and 6 months
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heart rate variability will be measured by placing electrodes near the heart similar to an EKG.
Changes in heart rate variability from baseline to 3 and 6 months will be examined.
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baseline, 3 months, and 6 months
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Change in protective stepping as determined by the number of steps it take to recover from a balance perturbation from baseline to 3 months and baseline to 6 months
Lasso di tempo: baseline, 3 months, and 6 months
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A machine that pulls individuals side to side will be used to measure the number of steps required to recover balance after a pull.
Changes from baseline to 3 and 6 months will be examined.
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baseline, 3 months, and 6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in clinical balance as measured by the Four Square Step Test
Lasso di tempo: baseline, 3 months, and 6 months
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The Four Square Step Test (FSST) will be used to evaluate changes in clinical balance.
The FSST is a single item, evaluator-administered tool that assesses the ability to change directions while stepping.
It requires the individuals to move in the anterior-posterior and medial-lateral directions while stepping.
Changes from baseline to 3 and 6 months will be examined.
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baseline, 3 months, and 6 months
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Change in mobility as measured by the modified physical performance test
Lasso di tempo: baseline, 3 months, and 6 months
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The modified physical performance test will be used to evaluate changes in mobility.
This test requires individuals to perform a variety of every day tests such as going up and down the stairs, standing from a chair, and putting on a coat.
Changes from baseline to 3 and 6 months will be examined.
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baseline, 3 months, and 6 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Odessa Addison, PhD, University of Maryland, Baltimore
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 maggio 2016
Completamento primario (Effettivo)
1 dicembre 2017
Completamento dello studio (Effettivo)
1 dicembre 2017
Date di iscrizione allo studio
Primo inviato
1 settembre 2015
Primo inviato che soddisfa i criteri di controllo qualità
2 settembre 2015
Primo Inserito (Stima)
4 settembre 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
31 gennaio 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 gennaio 2022
Ultimo verificato
1 gennaio 2022
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HP-00064233
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
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 .