Mobility Optimization Through Velocity Exercise (MOVE)
Optimizing Mobility in Older Adults With Knee Osteoarthritis
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Iowa
-
Iowa City, Iowa, Spojené státy, 52242
- University of Iowa
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
|
|
Komparátor placeba: Control
Gait Training Control Group Participants
|
There is no intervention associated with this arm of the study
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 200807706
- K23AG030945-01 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .