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Completed

NCT Number: NCT02374268

Intervention Assessing the Role of Exercise Program and Nutrition Supplement for Sarcopenia

Sarcopenia represents the loss of skeletal muscle and strength that occurs with aging. It is a major component of frailty and its effect on daily functioning, falls, and fractures has been well documented. Along with the population aging worldwide, the number of people with sarcopenia is expected to increase and, thus, contributing to dependency and the anticipated increase in health and social care costs. The cause of sarcopenia is multifactorial. Recent evidence suggests that some reversibility exists, highlighting the importance of intervention modalities. However, the role of nutritional supplementation and exercise programs, either individually or in combination, is still uncertain, and further randomized controlled trials (RCTs) have been recommended by the International Sarcopenia Initiative. Therefore, the investigators plan to conduct a 24-month RCT to compare the effectiveness of 12-week exercise program alone, combined exercise program and nutrition supplement, and non-exercise control group on improving muscle mass, strength and power and physical performance in Chinese older people who have sarcopenia defined using the Asian Working Group Criteria (AWGC). The investigators hypothesize that compared with the non-exercise control group, there will be improvement in muscle strength, power and mass, and physical performance in the exercise alone group, and that there will be an additive effect with the combined exercise and nutrition supplement group. Chinese older people aged 65 years and over will be recruited for a brief screening of sarcopenia and cognitive status. Potential subjects will further undertake detailed body composition and biochemical measurements to check for their eligibility. Eligible subjects will be randomized to one of the three groups: exercise program alone, combined exercise program and nutrition supplement, or waitlist control group with the same exercise program offered after 24-week of study enrollment. Each group will have 45 subjects. Outcome measurements including muscle strength, power and mass, physical performance, instrumental activities of daily living and related biochemical measurements will be made at baseline, 12 and 24 weeks.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese University of Hong Kong

Hong Kong, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Chinese origin
  • Normally reside in Hong Kong
  • Could speak and understand Chinese
  • With handgrip strength less than 26 kg for men and 18 kg for women and/or usual gait speed less than or equal to 0.8 m/s, as recommended by the Asian Working Group on Sarcopenia (AWGS)
  • With height-adjusted appendicular skeletal muscle mass (ASM/ht2) measured using dual X-ray absorptiometry (DEXA) less than 7.0 kg/m2 for men and 5.4 kg/m2 for women, as recommended by the AWGS
  • Willing to follow the study procedures

Exclusion criteria

  • Recent (i.e. past 3 months) or concurrent participation in any clinical trial or dietary and/or exercise intervention program
  • Self-reported allergy to the ingredients of the nutrition supplement
  • Use of medications that could affect study outcomes
  • With cancer conditions that are currently undergoing treatment
  • Poorly controlled or unstable chronic obstructive pulmonary disease
  • Poorly controlled or unstable cardiovascular disease or diabetes or hypertension
  • Recent unhealed bone fracture (within the past 12 months)
  • With medical advice or conditions prohibiting exercise or medical conditions that precluded safe participation in an exercise program
  • With any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study

Treatment and study plan

Exercise program alone

Behavioral

Combined exercise program and nutrition supplement

Dietary Supplement

Waitlist control group

Other

Primary outcomes

  1. Change in gait speed

    Time frame: baseline, 12 weeks

    This outcome will be measured using the 6-meter walk test

Secondary outcomes

  1. Handgrip strength

    Time frame: baseline, 12 weeks

    Handgrip strength will be measured using a dynamometer

  2. Bilateral leg extensors strength

    Time frame: baseline, 12 weeks

    Bilateral leg extensors strength will be measured by spring gauge while seated, and the average value between right and left will be used for analysis.

  3. Muscle power in the upper extremities

    Time frame: baseline, 12 weeks

    This outcome will be measured using seated 1.8kg medicine ball throw test (maximum throw distance achieved in 3 trials).

  4. Muscle power in the lower extremities

    Time frame: baseline, 12 weeks

    This outcome will be measured using 5-chair stand test (time to complete standing from a chair 5 times as quickly as possible).

  5. Height-adjusted appendicular skeletal muscle mass

    Time frame: baseline, 12 weeks

    This outcome will be measured using dual X-ray absorptiometry (DEXA)

  6. Improvement in sarcopenia category

    Time frame: baseline, 12 weeks

    This outcome will be measured using DEXA

  7. Health-related quality of life

    Time frame: baseline, 12 weeks

    This outcome will be measured using validated Chinese version of short form (SF)-12

  8. Instrumental Activities of Daily Living (IADL)

    Time frame: baseline, 12 weeks

    Participants will be asked to self-report of any impairment in walking two to three blocks outdoors on level ground, climbing 10 steps without resting, preparing own meals, doing heavy housework like scrubbing floors or washing windows, and shopping for groceries or clothes. A summed score from 0 to 5 was calculated from these activities as the degree of impairment in IADLs, with higher score indicating greater impairment.

  9. Cardiorespiratory fitness

    Time frame: baseline, 12 weeks

    Cardiorespiratory fitness will be measured by 6-minute walk test (6MWT). 6MWT will be completed and scored as the total number of meters walked in 6 minutes.

  10. Serum cystatin C measurement measured using immunoassay method

    Time frame: baseline, 12 weeks

    For combined exercise program and nutrition supplement group only

  11. Renal function test measured by University Pathology Service

    Time frame: baseline, 12 weeks

    For combined exercise program and nutrition supplement group only

Other outcomes

  1. Fasting blood samples for genetic study of genes related to physical function, sarcopenia and frailty

    Time frame: baseline, 12 weeks

  2. Change in gait speed

    Time frame: 12 weeks, 24 weeks

    This outcome will be measured using the 6-meter walk test

  3. Handgrip strength

    Time frame: 12 weeks, 24 weeks

    Handgrip strength will be measured using a dynamometer

  4. Bilateral leg extensors strength

    Time frame: 12 weeks, 24 weeks

    Bilateral leg extensors strength will be measured by spring gauge while seated, and the average value between right and left will be used for analysis.

  5. Muscle power in the upper extremities

    Time frame: 12 weeks, 24 weeks

    This outcome will be measured using seated 1.5kg medicine ball throw test (maximum throw distance achieved in 3 trials).

  6. Muscle power in the lower extremities

    Time frame: 12 weeks, 24 weeks

    This outcome will be measured using 5-chair stand test (time to complete standing from a chair 5 times as quickly as possible).

  7. Height-adjusted appendicular skeletal muscle mass

    Time frame: 12 weeks, 24 weeks

    This outcome will be measured using DEXA

  8. Improvement in sarcopenia category

    Time frame: 12 weeks, 24 weeks

    This outcome will be measured using DEXA

  9. Health-related quality of life

    Time frame: 12 weeks, 24 weeks

    This outcome will be measured using validated Chinese version of SF-12

  10. Instrumental Activities of Daily Living

    Time frame: 12 weeks, 24 weeks

    Participants will be asked to self-report of any impairment in walking two to three blocks outdoors on level ground, climbing 10 steps without resting, preparing own meals, doing heavy housework like scrubbing floors or washing windows, and shopping for groceries or clothes. A summed score from 0 to 5 was calculated from these activities as the degree of impairment in IADLs, with higher score indicating greater impairment.

  11. Cardiorespiratory fitness

    Time frame: 12 weeks, 24 weeks

    Cardiorespiratory fitness will be measured by 6-minute walk test (6MWT). 6MWT will be completed and scored as the total number of meters walked in 6 minutes.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Intervention for Sarcopenia Among Older Chinese Adults: A Randomized Controlled Trial Assessing the Role of Exercise Program and Nutrition Supplement

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2015
Registry last updated
Jan 12, 2018

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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