- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07696195
The Effectiveness of Resistance Training for Patients With Degenerative Arthritis After Surgery (Arthritis)
The Effectiveness of Resistance Training for Patients With Degenerative Arthritis After Surgery- A Pilot Randomized Controlled Study
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
This study employed an interventional, experimental design with a three-month follow-up to investigate the effectiveness of a progressive lower extremity resistance training program for patients with osteoarthritis following unilateral total joint arthroplasty. The study adhered to the CONSORT guidelines for reporting clinical trials.
Participants were randomly allocated into two groups:
- Control Group: Received routine postoperative rehabilitation care.
Experimental Group: Received a progressive lower extremity resistance exercise program in addition to routine care. The program utilized 1-kg ankle weights and included seated knee extension, standing hamstring curls, and hip abduction. Training sessions were performed three times per week for three months, with the training volume progressively adjusted as follows:
- 1st Postoperative Month: Performed on the non-operated limb only (2 sets per exercise).
- 2nd Postoperative Month: Continued on the non-operated limb (3 sets) and introduced to the operated limb (2 sets).
- 3rd Postoperative Month: Increased to 4 sets for the non-operated limb and 3 sets for the operated limb.
Each set consisted of 10 repetitions with a 1-minute rest between sets. Participants also received an illustrated exercise leaflet to enhance safety and adherence.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Taiwan
-
Hualien City, Taiwan, Taiwan, 97060
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Diagnosis of osteoarthritis requiring first-time unilateral lower limb total joint arthroplasty
- No planned surgery on the contralateral limb
- Clear consciousness and ability to communicate in Mandarin or Taiwanese
- Independent ambulation before surgery
- Adequate vision and hearing (with correction if needed)
- Community-dwelling status
- Willing to participate in this study
Exclusion Criteria:
- Inability to ambulate independently
- Medical contraindications to exercise
- Severe musculoskeletal conditions other than osteoarthritis
- Same-day admission and surgery
- Bilateral joint arthroplasty
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Experimental Group
Participants received a progressive lower extremity resistance exercise program using 1-kg ankle weights (including seated knee extension, standing hamstring curls, and hip abduction) 3 times per week for 3 months, in addition to routine postoperative care.
|
A 3-month progressive resistance training program utilizing 1-kg ankle weights, including seated knee extension, standing hamstring curls, and hip abduction.
Training sessions were performed 3 times per week, with progressive adjustments in training volume (sets and repetitions) for both operated and non-operated limbs over the 3-month period.
|
|
Active Comparator: Control Group
Participants received routine postoperative rehabilitation care.
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Participants in the control group received routine postoperative rehabilitation care.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Lower Extremity Muscle Endurance
Aikaikkuna: A higher number of completed stands means a better outcome (better lower extremity muscular endurance). To ensure safety for postoperative patients, a four-legged walker is placed in front of the chair during testing.
|
Assessed using the 30-Second Chair Stand Test.
This test measures the total number of completed stands a participant can perform from a seated position to a full stand within 30 seconds.
|
A higher number of completed stands means a better outcome (better lower extremity muscular endurance). To ensure safety for postoperative patients, a four-legged walker is placed in front of the chair during testing.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Balance Performance
Aikaikkuna: Shorter completion times (fewer seconds) mean a better outcome (better dynamic balance performance).
|
Assessed using the 2.44-Meter Timed Up-and-Go-Based Chair Rise and Obstacle Navigation Test, which measures the time (in seconds) taken to complete the functional mobility task.
|
Shorter completion times (fewer seconds) mean a better outcome (better dynamic balance performance).
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pain Intensity
Aikaikkuna: The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores mean a worse outcome (greater pain intensity). All assessments are conducted by the same researcher to ensure consistency.
|
Assessed using the Visual Analog Scale (VAS).
|
The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores mean a worse outcome (greater pain intensity). All assessments are conducted by the same researcher to ensure consistency.
|
|
quality of life
Aikaikkuna: This 28-item instrument covers physical health, psychological well-being, social relationships, and environmental factors. The total score ranges from 28 to 112 ,Higher scores mean a better outcome (better perceived quality of life).
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Assessed using the Taiwan version of the World Health Organization Quality of Life-Brief Version (WHOQOL-BREF).
|
This 28-item instrument covers physical health, psychological well-being, social relationships, and environmental factors. The total score ranges from 28 to 112 ,Higher scores mean a better outcome (better perceived quality of life).
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- IRB114-014-B
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