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NCT Number: NCT06654648

Combined Exercise and Nutrition Intervention for Sarcopenia

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

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined exercise nutrition intervention group

Other

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 group

Other

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.

Primary outcomes

  1. 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)]

    Change from baseline 5-times chair stand test to 12 weeks after assessment, measured by 5-times chair stand test

Secondary outcomes

  1. Physical performance

    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.

Other outcomes

  1. Gait speed test

    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

  2. Appendicular skeletal muscle mass

    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)

  3. Health Related 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 quality of life using EQ-5D [range from 5 to 25 score]. Higher value means worse quality of life

  4. Basic and instrumental activities of daily living

    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.

  5. Sarcopenia screening questionnaire

    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

    • 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.
  6. Nutritional Assessment(questionnaire)

    Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]

    • Minimum nutritional assessment(MNA)
    • 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.
    • 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.
    • 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
  7. Nutritional Assessment(questionnaire)

    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.

  8. Handgrip strength

    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

  9. Delirium assessment

    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

  10. Physical acitivity assessment

    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

  11. Cognitive assessment

    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.

    • 0~17 points : obvious cognitive impairment
    • 18 to 23 points : Mild cognitive impairment
    • 24~30 points : No cognitive impairment
  12. Psychiatric state

    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]

    • 0~4 points : normal
    • 5~9 points : mild depression
    • 10 points or more : severe depression
  13. Swallowing assessment

    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)

  14. Empowerment assessment

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Eunsuk Kim, bachelor

CONTACT

[email protected]

01089353081

Yongchan Ha, phD

CONTACT

[email protected]

01085218328

Sponsors and collaborators

Lead sponsor

Seoul Bumin Hospital

Other

Collaborators

  • National Evidence-Based Healthcare Collaborating Agency

Registry information

Official study title

Combined Exercise and Nutrition Intervention for Sarcopenia in Patients With Hip Fracture: CENTERS; A Multicenter Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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