CERgAS: multiComponent Exercise and theRApeutic lifeStyle intervention to improve physical function and maintain independent living among urban poor older people

Plain English summary of protocol

Background and study aims
People around the world are living longer, and this is rapidly changing demographic patterns in societies such as the average lifespan and age. Malaysia, a developing nation, is no exception. The proportion of older Malaysians (aged 60 years and above) is expected to double from 6.3% (1.4 million) in 2000 to 12% (4.9 million) by 2030. As people age, they may become frail, physically disabled and simply not able to do the things they used to be able to do. This can mean that they become more reliant on healthcare in both the short and the long term and this can, in turn, lead to an increase in the cost of public healthcare and services. Frailty is becoming increasingly common with advancing age, resulting in a spiral of physical decline. It leads to weight loss, extreme tiredness, lack of energy, slow movements, loss of muscle and muscle weakness. Frail older people are more likely to fall, become less mobile, become dependent on the help of other people for their day-to-day activities (ADL), become disabled, be admitted to hospital or be admitted to an institution such as a nursing home. Frailty inevitably affects a person’s well-being, leads to an increase in individual healthcare costs and can result in death. Since being physically able to enjoy their day-to-day activities (functional status) can be used to assess quality of life among older people, treatments (interventions) that either delay the onset of frailty or make it less severe are likely to be beneficial not only to the elderly people concerned but also their families and society at large. In this study we aim to develop and assess the performance of a six-week multiComponent Exercise and theRApeutic lifeStyle (CERgAS) intervention program aimed at improving the physical capabilities of older people in a poor urban area and ensure that they can continue to live independent lives. This study also hopes to identify the group of older people that will benefit the most from this intervention.

Who can participate?
Older persons aged 60 years and above, residing in a low-cost government subsidized flat in Klang Valley (a cosmopolitan area covering 10 municipalities: Kuala Lumpur, Subang Jaya, Petaling Jaya, Selayang, Shah Alam, Ampang Jaya, Putrajaya and Sepang), independently mobile with a walking speed of <1.24 m/s for females and <1.33 m/s for males, willing and able to attend a one-hour session twice weekly for 6 weeks, and who do not suffer from unstable cardiovascular disease, other uncontrolled chronic conditions, recent fractures and musculoskeletal diseases.

What does this study involve?
Participants are randomly allocated to either a intervention or control group. Those in the intervention group attend a total of 12 sessions that take place twice a week over a six-week period. These include group exercise sessions and also sessions covering nutrition and oral care. Ongoing support and counselling will be provided through bi-weekly phone calls. People in the control group receive a general health education booklet containing information on a healthy lifestyle.

What are the possible benefits and risks of participating?
Participants will be empowered to adopt a healthy lifestyle with the regular exercise sessions, nutrition and oral care education. It is anticipated that they will improve physically, benefit from better nutrition and that their oral health will improve. While there are no potential risks of participation, any adverse events observed including muscle soreness, pain or injuries will be documented and promptly looked at by a healthcare professional.

Where is the study run from?
The study will take place at 8 randomly selected low-cost government subsidised flats in Klang Valley.

When is the study starting and how long is it expected to run for?
The study will commence in September 2014 and run for 10 months.

Who is funding the study?
The University of Malaya (Malaysia)

Who is the main contact?
Associate Professor Dr Noran Naqiah binti Mohd Hairi
noran@um.edu.my

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Malaysia

Study participating centre

Sponsor information

University of Malaya (Malaysia)
University/education

c/o Ms Devi Peramalah
Julius Centre University of Malaya
Department of Social and Preventive Medicine
Faculty of Medicine
Kuala Lumpur
50603
Malaysia

Email	devi@ummc.edu.my
Website	http://spm.um.edu.my/
"ROR"	https://ror.org/00rzspn62

Funders

Funder type

University/education

Results and Publications

Study outputs

Editorial Notes

17/07/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
19/04/2016: Publication reference added.
On 22/09/2014 the following changes were made to the trial record:
1. The overall trial start date was changed from 01/08/2014 to 01/09/2014.
2. The overall trial end date was changed from 31/05/2015 to 30/06/2015.
3. The target number of participants was changed from 290 to 164.