The Effectiveness of an Elastic Band -Based Progressive Resistance Training (EB-PRT) in Improving Sarcopenia and Clinical Outcomes Among Patients With Heart Failure: A Pilot Mixed-method Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Heart failure (HF) is a complicated clinical syndrome caused by structural and/or functional cardiac abnormalities that result in ineffective myocardial pumping. HF management has placed more emphasis on improving the prognostic factors which determine these poor clinical outcomes. More recently, the prognostic role of sarcopenia in HF has received particular attention. Defined as progressive and generalized decline in skeletal muscle mass, strength and physical performance due to aging, sarcopenia is definitely a common comorbid of HF which follows an age-specific disease epidemiology. Given muscle disuse is the most preventable and reversible factor of sarcopenia, more evidence points to the therapeutic value of resistance training (RT) for this debilitating condition. Nevertheless, the therapeutic effects of RT on improving sarcopenia and thereby the disease prognosis among HF patients is yet to be evaluated. Therefore, the sequential mixed method study including a pilot RCT will be conducted to evaluate the preliminary effect of a 14-week elastic band-progressive resistance training (EB-PRT) and a subsequent qualitative study to explore the subjects' engagement experience. The outcomes cover the whole set of defining characteristics including muscle mass, muscle strength and functional performance and the clinical outcomes which reflect HF disease severity and patient-reported HRQL.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• age ≥ 50;

• has a confirmed clinical diagnosis of HF in the electronic health record for at least 6 months to ensure adequate disease exposure;

• meeting the Asian Working Group of Sarcopenia's criteria2 \[grip strength measured by dynamometer (Male: \<28kg; Female: \<18kg); low physical function (defined by Short Physical Performance Battery score ≤9) and reduced muscle mass by bioimpedance analysis (Inbody Technology 270; Male: appendicular skeletal muscular index (ASMI) \<7.0kg/m2, Female: \<5.7kg/m2)\];

• has stable HF and do not have any acute respiratory and musculo-skeletal condition which contradict them from practising exercise;

• no regular resistance training for the previous 6 months.

Locations
Other Locations
Hong Kong Special Administrative Region
The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Doris Sau Fung YU, PhD
dyu1@hku.hk
852 3817 6319
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 62
Treatments
Experimental: EB-PRT
EB-PRT will implemented during week 1-14. A purposive sample of 12 participants invited for qualitative interview during 21st -22nd week. There are 2 post-test evaluations at 14th week and 26th week. After the second evaluation at week 26, the group will receive usual care with routine follow-up.
No_intervention: Usual care
The control group will receive usual care including the medical care offered by the specialist out-patient clinic during 1-26 week. There are 2 post-test evaluations at 14th week and 26th week. From week 27 to week 40, this wait-list control group will receive the same EB-PRT as the intervention group.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Authority, Hong Kong
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov