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Thinking, Walking Outcomes by Type of Exercise (2-STEP)

28. juli 2015 opdateret af: University of Pittsburgh

Benefits of Two Types of Therapeutic Exercise on Gait and Cognition

The purpose of this research study is to compare two different exercise treatments for walking problems in older adults. The investigators want to determine if participation in the exercise programs will improve walking and thinking abilities.

Studieoversigt

Detaljeret beskrivelse

Specific Aims We will examine the impact of moderate intensity aerobic and of motor skill exercise interventions on improving gait and cognition in older adults with slow gait and psychomotor slowing. In a thrice weekly, 12 week, randomized clinical trial, we propose the following aims: 1) to define the impact of moderate intensity aerobic and motor skill gait exercise on thinking while walking, and 2) to define the impact of moderate intensity aerobic and motor skill gait exercise on gait and cognition. Brief Background The optimal exercise to improve gait and brain health in older adults is not known. Two types of exercise with potential for affects on gait and brain health, aerobic and motor skill exercise, developed out of distinct disciplines and have been studied separately, but not in older adults with the same age-related, centrally-generated slow gait dysfunction or for their effects on an integrated measure of gait and cognition, 'walking while thinking'. Summary of Methods We propose two parallel, single arm clinical trials to define the impact of aerobic and motor-skill exercise on gait and cognitive functions, in community-dwelling older adults with slow gait and psychomotor slowing, randomly assigned to moderate intensity aerobic gait (n=12) or motor skill gait (n=12) exercise, three times a week, for 12 weeks, in small groups of 2-3 supervised by a physical therapist. Primary outcomes are integrated measures of thinking while walking, with secondary outcomes of specific measures of gait and cognitive function collected pre, 4, 8 and 12 weeks post interventions, to examine impact of exercise and dose-response effects on gait and cognition. Future Use of Data The intent of the proposed pilot is to generate complementary data essential to support an R01 clinical trial grant submission. Specifically in this pilot we will: 1) recruit older adults with both slow gait speed and evidence of psychomotor slowing, 2) explore and define a primary outcome measure that integrates both gait and cognition, and thus better represents the goal of the exercise interventions - thinking while walking, 3) determine potential mean and variability estimates for gait and cognitive outcomes, particularly the less well-characterized gait outcomes of aerobic exercise (energy expenditure for walking, gait variability, gait abnormalities), and cognitive outcomes of motor skill exercise (speed of processing, executive function).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15260
        • University of Pittsburgh, Department of Physical Therapy

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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • slow gait speed (<= 1.0m/s and >= .6m/s)
  • slow cognitive processing (digit symbol substitution < age-adjusted norm
  • medical clearance from primary physician for participation in exercise

Exclusion Criteria:

  • dementia or Mild Cognitive Impairment MCI
  • pain while walking that limits walking
  • active medical conditions, not controlled or managed

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: motor skill gait exercise arm
motor skill gait exercise intervention: stepping and walking patterns, and speed interval treadmill-assisted walking to enhance timing and coordination in walking
The motor skill gait exercise is a task-oriented motor sequence learning approach to exercise to improve walking. The approach involves goal-directed stepping and walking patterns to facilitate use of the appropriate muscles at the appropriate timing relative to body position during gait through the task performance. Treadmill-assisted walking in brief intervals of small increased speed walking interspersed with usual walking speed are performed to induce the automatic rhythm and timing of gait. The exercise sessions are about 60 minutes, 2-3 times a week for 12 weeks or a total of 30-36 sessions.
Andre navne:
  • task-oriented motor sequence gait exercise
  • motor learning gait exercise
  • timing and coordination therapeutic gait activity
Aktiv komparator: aerobic gait exercise arm
aerobic gait exercise intervention: treadmill-assisted and overground walking exercise to enhance walking practice and improve endurance in walking
The aerobic gait intervention approach involves treadmill and overground walking with the gradual increases in the distance walked and speed of walking. The exercise approach provides walking practice, including on the treadmill to facilitate the timing of stepping during gait, while also facilitating a fitness or conditioning response, and endurance for walking activities. The exercise sessions are about 60 minutes, 2-3 times weekly for 12 weeks, or about 30-36 sessions.
Andre navne:
  • walking endurance exercise
  • aerobic walking training
  • impairment-oriented gait exercise

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
integrated measure of thinking while walking
Tidsramme: 12 weeks
The outcome measure is a cognitive task such as working memory, visual-spatial orientation, and set shifting measures of cognitive function performed while walking over an oval track.
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
gait
Tidsramme: 12 weeks
energy cost of walking, gait smoothness, gait speed and spatial and temporal gait characteristics under usual and challenging gait conditions, gait abnormalities, and walking endurance
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Jessie M VanSwearingen, PhD, PT, University of Pittsburgh, Department of Physical Therapy

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

1. januar 2011

Primær færdiggørelse (Faktiske)

1. maj 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

22. juni 2012

Først indsendt, der opfyldte QC-kriterier

6. juli 2012

Først opslået (Skøn)

9. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2015

Sidst verificeret

1. juni 2012

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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