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Mobility Optimization Through Velocity Exercise (MOVE)

2. maj 2016 opdateret af: Neil A Segal, University of Iowa

Optimizing Mobility in Older Adults With Knee Osteoarthritis

Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The purpose of this research is to reduce disablement of older adults with symptomatic knee osteoarthritis.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The long-term objective of this research is to reduce disablement of older adults with knee osteoarthritis (OA). This will be accomplished through assessing changes in functional limitations (standing and walking) that occur with 2 mobility-specific interventions. The principle of specificity of training indicates that exercises that closely approximate the goal functional activity are most effective in improving physical performance during that activity. However, there is uncertainty whether intervening to increase muscle power or to improve gait mechanics would be most effective for optimizing mobility in older adults with knee OA. Although gait training may be most specific for improving gait, this approach currently requires supervised physical therapy and expensive equipment. In contrast, power training may be less costly and more convenient if conducted at home. To optimize mobility in older adults with symptomatic knee OA, there is a need to study each of these mobility-specific interventions in a randomized controlled trial (RCT). Successful completion of this trial will inform rehabilitation for maintaining or improving mobility as well as explore the mechanism of effect.

Specific Aim 1: Assess the efficacy of two innovative interventions for improving mobility limitations, disability and quality of life in older adults with symptomatic knee OA.

Primary Hypothesis: For older adults with symptomatic knee OA, in comparison with usual care (control group), a 3-month a) patient-specific gait training intervention and b) mobility-specific power training intervention will reduce lower limb mobility limitations assessed using the Function component of the Late Life Function and Disability Index (LLFDI-Function).

Hypothesis 2: Improved mobility will be maintained at 6 and 12-month follow-up (3 and 9 months following transitioning to home-based training) for each of the 2 intervention groups who receive the combination of the home-based intervention and encouragement to continue participation.

Hypothesis 3: In comparison to baseline measures, at 3, 6, and 12-month follow-up, each of the 2 intervention groups will demonstrate improvements in a) disability (LDCW), b) quality of life assessed using the Knee Osteoarthritis Outcome Score questionnaire Quality of Life component(KOOS Knee QOL), and c) knee OA specific outcome scores using the pain subscale component of KOOS.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

58

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa

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

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 60 or older
  • Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by x-ray and frequent knee symptoms)

Exclusion Criteria:

  • bilateral knee replacement
  • acute or terminal illness
  • unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring use of supplement oxygen, or current medical condition that affects walking, or lower limb musculoskeletal surgery in the past 6 months

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gait Training
Gait Training Intervention Group Participants
Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months
Placebo komparator: Control
Gait Training Control Group Participants
There is no intervention associated with this arm of the study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument
Tidsramme: 0,3,6, and 12 months

This is a questionnaire that evaluates self-reported difficulty in a person's ability to do discrete actions or activities primarily involving standing, stooping and fundamental walking activities without the help of others. Factors that may influence difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailments, health conditions and disabilities.

Scored from 14 to 70 with scores approaching 70 signifying high levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance), and scores approaching 14 signifying low levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance).

0,3,6, and 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain
Tidsramme: 0,3,6 and 12 months

This is a 42-item self-administered questionnaire that covers five patient-relevant dimensions, including pain and knee-related symptoms. This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods.

Scored from 0 to 100 with 100 indicating no pain.

0,3,6 and 12 months
Change in KOOS Symptoms
Tidsramme: 0,3,6 and 12 months

This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods.

Scored from 0 to 100 with 100 indicating no symptoms.

0,3,6 and 12 months
Change in Long Distance Corridor Walk (LDCW) Time, Secs
Tidsramme: 0,3,6 and 12 months
The LDCW included both 2-min walk distance and 400-m walk time. This measure has been shown to be predictive of changes in community mobility. Per the LDCW protocol, for participants unable to walk 400 m, gait speed was estimated from the 2-min walk distance, so that all participant data were on the same scale.
0,3,6 and 12 months
Change in Stair Climb Time, Secs
Tidsramme: 0,3,6, and 12 months
Functional limitations specific to ascending stairs were assessed with a times stair climb, using a standard eight-stair flight (stair height = 19 cm)
0,3,6, and 12 months
Change in Chair Stand Time
Tidsramme: 0,3,6,and 12 months
Measured as the total time (in seconds) required to stand five times from a seated position in a standardized chair without using arms.
0,3,6,and 12 months

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

1. august 2008

Primær færdiggørelse (Faktiske)

1. oktober 2010

Studieafslutning (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

13. februar 2009

Først indsendt, der opfyldte QC-kriterier

13. februar 2009

Først opslået (Skøn)

16. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 200807706
  • K23AG030945-01 (U.S. NIH-bevilling/kontrakt)

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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