Clinical trial NCT02374268: Intervention Assessing the Role of Exercise Program and Nutrition Supplement for Sarcopenia
Official title: Intervention for Sarcopenia Among Older Chinese Adults: A Randomized Controlled Trial Assessing the Role of Exercise Program and Nutrition Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 113
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in gait speed
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Handgrip strength
timeFrame: baseline, 12 weeks
measure: Bilateral leg extensors strength
timeFrame: baseline, 12 weeks
measure: Muscle power in the upper extremities
timeFrame: baseline, 12 weeks
measure: Muscle power in the lower extremities
timeFrame: baseline, 12 weeks
measure: Height-adjusted appendicular skeletal muscle mass
timeFrame: baseline, 12 weeks
measure: Improvement in sarcopenia category
timeFrame: baseline, 12 weeks
measure: Health-related quality of life
timeFrame: baseline, 12 weeks
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: baseline, 12 weeks
measure: Cardiorespiratory fitness
timeFrame: baseline, 12 weeks
measure: Serum cystatin C measurement measured using immunoassay method
timeFrame: baseline, 12 weeks
measure: Renal function test measured by University Pathology Service
timeFrame: baseline, 12 weeks
Other outcomes:
measure: Fasting blood samples for genetic study of genes related to physical function, sarcopenia and frailty
timeFrame: baseline, 12 weeks
measure: Change in gait speed
timeFrame: 12 weeks, 24 weeks
measure: Handgrip strength
timeFrame: 12 weeks, 24 weeks
measure: Bilateral leg extensors strength
timeFrame: 12 weeks, 24 weeks
measure: Muscle power in the upper extremities
timeFrame: 12 weeks, 24 weeks
measure: Muscle power in the lower extremities
timeFrame: 12 weeks, 24 weeks
measure: Height-adjusted appendicular skeletal muscle mass
timeFrame: 12 weeks, 24 weeks
measure: Improvement in sarcopenia category
timeFrame: 12 weeks, 24 weeks
measure: Health-related quality of life
timeFrame: 12 weeks, 24 weeks
measure: Instrumental Activities of Daily Living
timeFrame: 12 weeks, 24 weeks
measure: Cardiorespiratory fitness
timeFrame: 12 weeks, 24 weeks
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
Study officials:
References:
citation: Zhu LY, Chan R, Kwok T, Cheng KC, Ha A, Woo J. Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial. Age Ageing. 2019 Mar 1;48(2):220-228. doi: 10.1093/ageing/afy179.