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

NCT ID: NCT02374268

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-10-25

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise program alone

There will be 2 site sessions and 1 home session per week for 12 weeks. Each site exercise session will begin and end with a 5-10 minute warm-up and cool-down routine. The first part of the exercise program consists of 20-30 minute chair-based resistance exercises using Thera-Bands for muscle groups in both the upper and lower body. To target the development of muscle power in both the lower and upper extremities, participants will be instructed to perform each concentric movement 'as rapidly as possible,' and the eccentric movement in a slow and controlled manner. A 5-minute rest period will be given prior to the start of the second part of the exercise program that consists of aerobic exercises such as ball games using fitballs or Taichi. Participants will be asked to spend an hour/week on home exercise. Thera-Bands and a leaflet showing the exercise procedures will be given to them and their caregivers.

Group Type: EXPERIMENTAL

Exercise program alone

Intervention Type: BEHAVIORAL

Exercise program plus nutrition supplement

This group will receive both the exercise program as well as the nutrition supplement. The components of the exercise program will be same as those of the exercise program alone group. Participants will also be asked to consume two sachets of Ensure NutriVigor every day during the 12-week intervention period. Ensure NutriVigor (one sachet of 54.1 g powder) contains 231 calories, 8.61 g protein, 1.21 g hydroxyl-methyl-butyrate (HMB), 130 IU vitamin D, and 0.29 g omega 3 fatty acid per serving. Participants will be instructed on how to prepare the supplement.

Group Type: EXPERIMENTAL

Exercise program alone

Intervention Type: BEHAVIORAL

Combined exercise program and nutrition supplement

Intervention Type: DIETARY_SUPPLEMENT

Waitlist control group

This group will be asked to maintain their usual physical activities and dietary habits during the first 6 months of study period. After they complete the 24-week measurement, they will receive the same 12-week exercise program as of the exercise program alone group.

Group Type: OTHER

Waitlist control group

Intervention Type: OTHER

Interventions

Exercise program alone

Intervention Type: BEHAVIORAL

Combined exercise program and nutrition supplement

Intervention Type: DIETARY_SUPPLEMENT

Waitlist control group

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Ruth Chan

Research assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chinese University of Hong Kong

Hong Kong, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 30462162 (View on PubMed)

Other Identifiers

2014.648-T

Identifier Type: -

Identifier Source: org_study_id