scholarly journals The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial

2010 ◽  
Vol 10 (1) ◽  
Author(s):  
Silke F Metzelthin ◽  
Erik van Rossum ◽  
Luc P de Witte ◽  
Marike RC Hendriks ◽  
Gertrudis IJM Kempen
2019 ◽  
Vol 99 (12) ◽  
pp. 1616-1627
Author(s):  
Justina Y W Liu ◽  
Patrick P K Kor ◽  
Paul L Lee ◽  
Wai T Chien ◽  
Parco M Siu ◽  
...  

Abstract Background Although the evidence suggests that general fatigue is a strong indicator of rapid aging, frailty, and disability, general fatigue is undertreated in gerontological care. Objective The aim of this study is to investigate whether an individualized exercise program with and without behavioral change enhancement (BCE) strategies for older people who are frail and have general fatigue will reduce their fatigue and symptoms of frailty. Design A 3-arm, single-blind, cluster randomized controlled trial registered with ClinicalTrials.gov (NCT03394495) will be conducted. Setting The study will be conducted in a community setting. Participants Two hundred eighty-five community-dwelling older people with general fatigue will be recruited from 12 district community health centers. Intervention People from each center will be randomized to one of three groups. The combined group will receive a 16-week combined intervention consisting of individualized exercise training and the BCE program, plus two booster sessions at 2 and 6 months after the program. The exercise group will receive exercise training and health talks only. The control group will receive health talks only. Measurements Outcome measures will be collected at baseline, at the midpoint (week 8) of the program, and then at 1 week, 6 months, and 12 months after the end of the program. The primary outcome---level of fatigue---will be measured using the Multidimensional Fatigue Inventory. Secondary outcomes will include the participants’ frailty status, strength, mobility, exercise self-efficacy, and habitual physical activity. Limitations A self-reported level of fatigue will be used. Conclusions The effect of exercise and BCE strategies on general fatigue among older people who are frail is not known. This study will be a pioneering interventional study on how general fatigue among older people who are frail can be managed and how fatigue-related frailty can be prevented or minimized.


2019 ◽  
Vol 35 ◽  
pp. 153331751987263 ◽  
Author(s):  
Juyoung Park ◽  
Magdalena I. Tolea ◽  
Diane Sherman ◽  
Amie Rosenfeld ◽  
Victoria Arcay ◽  
...  

This study assessed the feasibility of conducting 3 nonpharmacological interventions with older adults in dementia, exploring the effects of chair yoga (CY), compared to music intervention (MI) and chair-based exercise (CBE) in this population. Using a cluster randomized controlled trial (RCT), 3 community sites were randomly assigned 1:1:1 to CY, MI, or CBE. Participants attended twice-weekly 45-minute sessions for 12 weeks. Thirty-one participants were enrolled; 27 safely completed the interventions and final data collection (retention rate of 87%). Linear mixed modeling was performed to examine baseline and longitudinal group differences. The CY group improved significantly in quality of life compared to the MI group (CY mean = 35.6, standard deviation [SD] = 3.8; MI mean = 29.9, SD = 5.3, P = .010). However, no significant group differences were observed in physical function, behavioral, or psychological symptoms (eg, for mini-PPT: slopetime = 0.01, standard error [SE] = 0.3, P = .984 in the CBE group; slopetime = −0.1, SE = 0.3, P = .869 in the MI group; slopetime = −0.3, SE = 0.3, P = .361 in the CY group) over the 12-week intervention period. Overall, this pilot study is notable as the first cluster RCT of a range of nonpharmacological interventions to examine the feasibility of such interventions in older adults, most with moderate-to-severe dementia. Future clinical trials should be conducted to examine the effects of nonpharmacological interventions for older adults with dementia on health outcomes.


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