- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03537677
Sit Less for Successful Aging
Sit Less for Successful Aging: A Sedentary Behavior Intervention for Older Adults in Independent Living Communities
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Aim 1: To measure the amount of sedentary time and ambulation (steps) in older adults residing in independent living communities.
Aim 2: To test the acceptability and effectiveness of a 12-week sedentary behavior intervention to decrease sitting and increase ambulation which will in turn improve physical function (primary outcome) as well as sleep, quality of life, energy/mood, pain and blood pressure (secondary outcomes) in independent living residents.
Background: Sedentary behavior, or sitting for prolonged periods during waking time, is identified as a health risk that is distinct from the failure to achieve sufficient physical activity. Older adults exhibit the greatest time in sedentary behavior which is concerning given its association with chronic disease and poorer physical function. Preliminary data suggest that individuals in long term care facilities may have even greater sedentary time due to personal factors and environment influences. Most often, exercise is targeted as a mechanism for ameliorating frailty in older adults; however, reduction in sedentary time may be a more appealing and realistic goal for improving health outcomes. Despite this, studies targeting sedentary time in older adults, particularly in those in independent living facilities, are lacking.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15219
- University of Pittsburgh
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age ≥ 60 years
- Reside in an independent living facility
- Ability to walk approximately 100 feet (length of a hallway) with or without an assistive device
Exclusion Criteria:
- Unable to provide informed consent
- Presence of a comorbid medical condition that would limit ability to stand and perform light activity (e.g. recent orthopedic injury/surgery involving the lower extremities, currently undergoing treatment for cancer,acute cardiovascular conditions)
- Presence of a skin condition that would prohibit the use of an activity device attached with medical tape to the thigh (e.g. open wound on the thigh, skin infection on the lower extremity)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Sedentary Behavior Intervention
A behavioral intervention that targets prolonged sitting and encourages frequent activity breaks.
|
This 12-week intervention targets a reduction in prolonged sitting and includes provision of a wrist-worn activity prompter and in-person group sessions with behavioral counseling.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Sedentary Behavior
Tidsram: Baseline to 12 weeks
|
Objectively measured minutes of sitting during waking hours measured using the ActivPAL physical activity monitor for a minimum of 5 days pre and post-intervention.
The ActivPAL is a thigh-mounted, compact device that classifies an individual's free-living activity into time spent in sedentary, standing, and walking behaviors.
|
Baseline to 12 weeks
|
Steps per Day
Tidsram: Baseline to 12 weeks
|
The number of steps per day measured using the ActivPAL activity monitor.
This monitor is worn for a minimum of 5 days before and after the intervention.
|
Baseline to 12 weeks
|
Short Physical Performance Battery
Tidsram: Baseline to 12 weeks
|
This performance-based measure of physical function is a battery of measures to assess standing balance, gait speed and lower extremity strength (time to complete five chair rises)
|
Baseline to 12 weeks
|
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a
Tidsram: Baseline to 12 weeks
|
This self-report measure of physical function has 10 questions that assess the ability to perform various activities that require physical capability.
|
Baseline to 12 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Andrea L Hergenroeder, PT, PhD, Assistant Professor, Department of Physical Therapy
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 17020397
Plan för individuella deltagardata (IPD)
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