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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374268
• Other study ID #: 2014.648-T
• Status: Completed
• Phase: N/A
• First received: February 12, 2015
• Last updated: January 11, 2018
• Start date: March 2015
• Est. completion date: October 25, 2017

Study information

• Verified date: January 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: October 25, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Behavioral:
• Exercise program alone

Dietary Supplement:
• Combined exercise program and nutrition supplement

Other:
• Waitlist control group

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting blood samples for genetic study of genes related to physical function, sarcopenia and frailty		baseline, 12 weeks
Other	Change in gait speed	This outcome will be measured using the 6-meter walk test	12 weeks, 24 weeks
Other	Handgrip strength	Handgrip strength will be measured using a dynamometer	12 weeks, 24 weeks
Other	Bilateral leg extensors strength	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.	12 weeks, 24 weeks
Other	Muscle power in the upper extremities	This outcome will be measured using seated 1.5kg medicine ball throw test (maximum throw distance achieved in 3 trials).	12 weeks, 24 weeks
Other	Muscle power in the lower extremities	This outcome will be measured using 5-chair stand test (time to complete standing from a chair 5 times as quickly as possible).	12 weeks, 24 weeks
Other	Height-adjusted appendicular skeletal muscle mass	This outcome will be measured using DEXA	12 weeks, 24 weeks
Other	Improvement in sarcopenia category	This outcome will be measured using DEXA	12 weeks, 24 weeks
Other	Health-related quality of life	This outcome will be measured using validated Chinese version of SF-12	12 weeks, 24 weeks
Other	Instrumental Activities of Daily Living	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.	12 weeks, 24 weeks
Other	Cardiorespiratory fitness	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.	12 weeks, 24 weeks
Primary	Change in gait speed	This outcome will be measured using the 6-meter walk test	baseline, 12 weeks
Secondary	Handgrip strength	Handgrip strength will be measured using a dynamometer	baseline, 12 weeks
Secondary	Bilateral leg extensors strength	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.	baseline, 12 weeks
Secondary	Muscle power in the upper extremities	This outcome will be measured using seated 1.8kg medicine ball throw test (maximum throw distance achieved in 3 trials).	baseline, 12 weeks
Secondary	Muscle power in the lower extremities	This outcome will be measured using 5-chair stand test (time to complete standing from a chair 5 times as quickly as possible).	baseline, 12 weeks
Secondary	Height-adjusted appendicular skeletal muscle mass	This outcome will be measured using dual X-ray absorptiometry (DEXA)	baseline, 12 weeks
Secondary	Improvement in sarcopenia category	This outcome will be measured using DEXA	baseline, 12 weeks
Secondary	Health-related quality of life	This outcome will be measured using validated Chinese version of short form (SF)-12	baseline, 12 weeks
Secondary	Instrumental Activities of Daily Living (IADL)	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.	baseline, 12 weeks
Secondary	Cardiorespiratory fitness	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.	baseline, 12 weeks
Secondary	Serum cystatin C measurement measured using immunoassay method	For combined exercise program and nutrition supplement group only	baseline, 12 weeks
Secondary	Renal function test measured by University Pathology Service	For combined exercise program and nutrition supplement group only	baseline, 12 weeks