A randomized trial for the beneficial effect of pre-operative intervention on physical frailty as a poor prognostic factor after surgery for gastrointestinal cancer in older adults

JRCT ID: jRCT1053240193

Registered date:22/11/2024

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: gastrointestinal cancers
• Date of first enrollment: 24/08/2017
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Home-based resistance exercises (seated knee extensions, standing leg raises, standing toe raises/toe taps, and squats) and consumption of amino acid jelly for 14 days preoperatively.

Outcome(s)

• Primary Outcome: postoperative complications

Secondary Outcome

1) prognosis 1 year after surgery
2) changes of values of comprehensive geriatric assessment (CGA)
3) changes of body composition
4) changes of physical functions
5) changes of several biochemical tests
6) changes of serum concentrations of myokines and vitamin D

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) the ambulatory patients aged 70 years or older in Osaka University Hospital expecting to undergo digestive operations for gastrointestinal cancers (e.g. stomach/duodenum, esophagus, colorectal, hepatic, gallbladder, bile duct, and pancreas) within stage 3
2) the subjects diagnosed as physical frailty (decline of grip strength and/or gait speed)

Exclude criteria

1) the subjects with effort angina, chronic heart failure and tachyarrhythmia
2) the subjects with chronic respiratory failure
3) the subjects with active multiple cancers
4) the subjects who undergo preoperative chemotherapy
5) the subjects not able to walk by themselves
6) the subjects with chronic kidney disease
7) the subjects with severe hepatic dysfunction
8) the subjects with cognitive impairment
9) the subjects participating other clinical investigations

Related Information

• Primary Sponsor: Rakugi Hiromi
• Source(s) of Monetary Support: JSPS KAKENHI
• Secondary ID(s): UMIN000024526