- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03607136
Early Detection of Disability and Health Promotion for Community-dwelling Elderly
Department of Physical Therapy, Tzu Chi University
Studieöversikt
Detaljerad beskrivning
Physical inactivity can result in physical frailty and sarcopenia. Physical frailty and sarcopenia are two common and mostly overlapping geriatric conditions, which may cause negative consequences of aging, such as disability, hospitalization and mortality.
Regular physical activity has been suggested to maintain or improve functional capacity and body composition, as well as delay aging process. Nevertheless, inactivity prevalence still significantly increases among older adults, especially those with a disability. One of the probable reasons is that the use of physical activities or exercise interventions is not tailored to the needs and capabilities of the elderly.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- age greater than 50 years
- able to follow simple instructions
- willing to participate and sign consent form
Exclusion Criteria:
- unstable angina or epilepsy
- severe visual deficits
- cognitive dysfunction
- other musculoskeletal conditions that will limit mobility
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: exercise training
Participants in the exercise training group received a 12-week exercise training.
|
Aerobic exercises, strengthening exercises, flexibility training for 60min, twice a week for 12 weeks
|
Inget ingripande: control
Participants in the control group did not receive any specific training programs instead of maintaining their usual activities of daily living.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Walking speed
Tidsram: Change from baseline at 12 weeks
|
Participants are asked to walk along a 14 m hallway.
The time taken to the middle 10 m is recorded to calculate walking speed (m/s).
|
Change from baseline at 12 weeks
|
Muscle strength
Tidsram: Change from baseline at 12 weeks
|
Muscle strength is assessed using hand-hold Dynamometers
|
Change from baseline at 12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Timed up and go test
Tidsram: Change from baseline at 12 weeks
|
Participants are asked to stand up, walk 3 m, turn around a cone, and return to a sitting position
|
Change from baseline at 12 weeks
|
Walking endurance
Tidsram: Change from baseline at 12 weeks
|
Participants are asked to walk back and forth along a 20-meter corridor and to cover the maximum distance possible in six minutes
|
Change from baseline at 12 weeks
|
Sit-to-stand test
Tidsram: Change from baseline at 12 weeks
|
Participants are asked to stand up and sit down 5 times.
|
Change from baseline at 12 weeks
|
Berg balance scale
Tidsram: Change from baseline at 12 weeks
|
It consists of 14 items, including sitting unsupported, standing unsupported, standing with eyes closed, standing with feet together, standing on one foot, turning to look behind, retrieving objective from floor, random standing, reaching forward with an outsrptretched arm, sit to stand, stand to sit, transfer, turning 360 degrees, stool stepping, scored from 0 to 4, "0" indicates the lowest level of function and "4" the highest level of function.
Total Score = 56.
|
Change from baseline at 12 weeks
|
Gait kinematics
Tidsram: Change from baseline at 12 weeks
|
Gait kinematics are assessed by angular displacement of lower limbs using shoe-worn inertial measurement unit based device
|
Change from baseline at 12 weeks
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
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
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB106-75-A-2
Läkemedels- och apparatinformation, studiedokument
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