Seoul Bumin Hospital
Seoul, 07590, South Korea
Location status: Recruiting
Location contact
EunSuk Kim, RN
CONTACT
YongChan Ha, MD, PhD
CONTACT
YongChan Ha, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06654648
This study aims to demonstrate the effect of combined exercise-nutrition intervention in old adults with sarcopenia. This study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-nutrition intervention with conventional medical care. Handgrip strength, gait speed, knee extensor muscle power, physical performance, muscle mass using DEXA, quality of life, activities of daily living, sarcopenia screening questionnaire, nutritional assessment will be evaluated on baseline, 12-weeks and 24-weeks after intervention
Interested in participating?
Request Info65 year–90 year
All sexes
Interventional
Not applicable
Seoul, 07590, South Korea
Location status: Recruiting
EunSuk Kim, RN
CONTACT
YongChan Ha, MD, PhD
CONTACT
YongChan Ha, MD, PhD
PRINCIPAL_INVESTIGATOR
The definition of sarcopenia is age-related loss of skeletal muscle and physical functions.
Sarcopenia is emerging health problem and increases medical expenditure as the population ages. Sarcopenia is closely related to chronic diseases and geriatric diseases.
In particular, patients with hip fracture showed a high prevalence of muscle loss and muscle weakness.
It has been reported exercise in sarcopenia patients helped the treatment of the diseases.
Also, it is recently demonstrated that combined exercise-nutrition intervention improved muscle function in elderly patients.
However, there is still not established standard protocol for the combined exercise-nutrition intervention.
Therefore, the aim of this trial is to compare the effects of combined exercise nutrition intervention in sarcopenia patients with multicenter, multidisciplinary, randomized controlled trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Combination Product: Combined exercise and nutrition intervention Combined exercise and nutrition intervention for 12 weeks (an introductory phase 3 weeks, an expanded phase 3 weeks, and a maintenance phase 6 weeks). Exercise intervention (each 60-min session) includes stretching, resistance exercise, and aerobic exercise according to protocol. Nutritional intervention includes investigating dietary habits and calculate insufficient protein intake using Mini Nutritional Aseessment (MNA) and Korean Protein Assessment Tool (KPAT) to provide customized diet and high protein drink.
Conventional medial care Conventional medical care service for 12weeks during intervention period. Usual care includes medical check-up and exercise and dietary counseling. They were given a brochure about exercise and protein rich foods at their first visit.
The control group patients maintain their usual amount of activity and diet during the 6-month evaluation period. usual activity and dietary habits.
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Change from baseline 5-times chair stand test to 12 weeks after assessment, measured by 5-times chair stand test
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Short Physical Performance Battery [range from 0 to 12 score] The scores range from 0 (worst performance) to 12 (best performance) with higher scores indicating better functionality. It is a group of measures that combines the results of the gait speed, chair stand and balance tests.
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
measured by 6 meter gait speed
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
measured using Dual-energy X-ray absorptiometry (DEXA)
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Evaluation of quality of life using EQ-5D [range from 5 to 25 score]. Higher value means worse quality of life
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Evaluation of basic and instrumental activities of daily living using Korean Activity of Daily Living (K-ADL), Korean Instrumental Activity of Daily Living (K-IADL) [range from 0 to 33]. Low value means poor ability of activities.
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Evaluation of quality of life using Strength, Assistance with walking, Rising from a chair, Climbing stairs and Falls (SARC-F) questionnair [range from 0 to 10] This questionnaire is named after the first letters of the five survey questions: strength, assistance in walking, rising from a chair, climbing stairs, and falls.
The SARC-F questionnaire is a screening tool that can be rapidly implemented by clinicians to identify probable sarcopenic patients. The questionnaire screens patients for self-reported signs suggestive of sarcopenia, which include deficiencies in strength, walking, rising from a chair, climbing stairs, and experiencing falls. Each of the self-reported parameters receives a minimum and maximum score of 0 and 2, respectively, with the greatest maximum SARC-F score being 10 Grading method
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
2)Korean Protein Assessment Tool(KPAT) Check the average amount and frequency of meals and snacks consumed daily, weekly, and monthly through a questionnaire to determine the average amount of protein consumed per day(protein intake: g/day).
3)Nutrition counseling The protein deficiency(g/day) is calculated from the daily target protein intake (g/day) calculated from the MNA results and the daily protein intake(g/day) confirmed from the PIAT results. Nutritional counseling advises that insufficient protein intake be consumed through protein powder.
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Evaluation of hand grip strength using Hand-held dynamometer
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Evaluation of delirium using Delirium Rating Scale (DRS) [range from 0 to 32 score]. Higher value means worse delrious status
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
measured by Korean Physical Activity Scale for the Elderly (K-PASE) [range from 0 to 1382.52 score]. Higher value means better physical status
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Evaluation of cognitive state using Korean Mini Mental Status Examination, 2nd edition (K-MMSE2) [range from 0 to 30 score] Evaluate the subject's cognitive function by answering a total of 30 questions in 6 areas and performing test sentences.
If the subject fails to provide an appropriate answer or fails to follow instructions, a score of 0 is given.
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Evaluation of psychiatric state using Short Form of Geriatric Depression Scale-Korea (SGDS-K) [range from 0 to 30 score]
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
measured by Standardized Swallowing Assessment (SSA)
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
measured by Korean version of Health Empowerment Scale (K-HES) [range from 8 to 40 score]. Higher value means better empowerment status
Contact information is provided by the study sponsor or research team.
Eunsuk Kim, bachelor
CONTACT
Yongchan Ha, phD
CONTACT
Seoul Bumin Hospital
Other
Combined Exercise and Nutrition Intervention for Sarcopenia in Patients With Hip Fracture: CENTERS; A Multicenter Randomized Controlled Trial
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