Sarcopenia
Conditions
Keywords
Sarcopenia, Older adults, Exercise, Nutrition, Standard intervention
Brief summary
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
Detailed description
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.
Interventions
OTHERCombined exercise nutrition intervention group
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.
OTHERConventional medial care group
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.
Sponsors
National Evidence-Based Healthcare Collaborating Agency
Seoul Bumin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients older than 65 years and under 90 years * patients who meet the criteria for the Asian Working Group for Sarcopenia (AWGS) 2019 * patients who had metabolic syndrome
Exclusion criteria
* patients with less than estimated glomerular filtration rate (eGFR) 30 * patients with musculoskeletal or chronic lung disease incapable of exercise * patients with untreated or uncontrolled cardiovascular disease which may affect muscle mass or performing exercise * patients less than 5 years after treatment of malignant tumor * patients with liver cirrhosis, diabetes and other chronic disease * patients who cannot perform combined exercise nutrition intervention for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-times chair stand test | [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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance | [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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life | [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 |
| Basic and instrumental activities of daily living | [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. |
| Sarcopenia screening questionnaire | [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 * Calculate the total score of the five questions answered by the subject. * Minimum 0 \ Maximum 10 points * If the score is 4 or higher, sarcopenia is suspected. |
| Nutritional Assessment(questionnaire) | [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)] | 1\) Minimum nutritional assessment(MNA) 1. Items: weight, weight (kg), exercise pad, nervous/mental problems, body mass index (kg/m2) Scoring: Add up a score between 0 and 3 for your answer to each question. 2. Items: residence, medication use, bedsore treatment, number of meals per day Scoring: Add up a score between 0 and 2 for your answer to each question. 3. Results * Malnutrition indicator score Malnutrition: \<17, Malnutrition Risk: 17-23.5 points, Normal: 24-30 points. * Daily target protein(g/day)= g x body weight MNA 24-30 points (nutritious): 1.2 g/kg/day MNA 17-23.5 points (at risk): 1.5 g/kg/day MNA \<17 points (malnutrition): 1.5 g/kg/day |
| Handgrip strength | [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 |
| Gait speed test | [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 |
| Physical acitivity assessment | [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 |
| Cognitive assessment | [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. * 0\ 17 points : obvious cognitive impairment * 18 to 23 points : Mild cognitive impairment * 24\ 30 points : No cognitive impairment |
| Psychiatric state | [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) \[range from 0 to 30 score\] * 0\ 4 points : normal * 5\ 9 points : mild depression * 10 points or more : severe depression |
| Swallowing assessment | [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) |
| Empowerment assessment | [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 |
| Delirium assessment | [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 |
| Appendicular skeletal muscle mass | [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) |
Countries
South Korea
Contacts
Primary ContactYongchan Ha, phD
Backup ContactEunsuk Kim, bachelor
Outcome results
None listed