Proximal femoral fracture Proximal femoral fracture
Conditions
Interventions
After rehabilitation, the affected leg is applied with moisturizing gel and placed in a sealed plastic bag, which is filled with 100% CO2 and left to act for 20 minutes. This is done once a day, two d
Sponsors
Fukui Tomoaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged 60 years or older at the time of consent. (2) Sex, no restriction. (3) Patients with a proximal femoral fracture for whom inpatient rehabilitation is planned. (4) Patients who meet either of the following, a) Patients scheduled to undergo surgery for the proximal femoral fracture. b) Patients who had rehabilitation initiated at another hospital within 5 weeks after surgery for a proximal femoral fracture and were subsequently transferred to the institusions participating the current clinical trial. (5) Patients who have voluntarily provided written informed consent to participate in this clinical study.
Exclusion criteria
Exclusion criteria: (1) Patients in whom >=5 weeks have elapsed after surgery for the proximal femoral fracture. (2) Patients with a skin disease of the fractured limb requiring treatment (e.g., atopic dermatitis). (3) Patients with an active infection in the fractured limb. (4) Patients with a pathological fracture. (5) Patients with a history of allergic reactions to carbon dioxide (CO2) gas or to a moisturizing gel. (6) Patients with a history of paralysis (hemiplegia or paraplegia). (7) Patients who have participated in another clinical trial within the past 4 months. (8) Patients who have previously undergone rehabilitation combined with CO2 therapy. (9) Patients with cardiac disease requiring restriction of exercise prescription, such as NYHA class 3-4, unstable angina, or myocardial infarction within the past 3 months. (10) Patients with impaired respiratory function whose SpO2 on room air is 88% or lower. (11) Patients anticipated at admission to require a short-term hospitalization of =< 4 weeks. (12) Any other patients deemed inappropriate by the investigator for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight normalized muscle mass of the affected lower limb at discharge compared with at admission. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events during hospitalization and, after discharge. Occurrence of [diseases, etc.] during the observation period (i.e., whether any [diseases, etc.] related to the protocol treatment occurred). If the same [disease, etc.] is observed multiple times in the same subject, the highest (worst) severity grade will be used. Change in weight-normalized muscle mass of the lower limb on the affected side at discharge, compared with admission. At discharge vs. admission, changes in body composition measured with the InBody S10-intracellular water, extracellular water, protein + mineral mass, body fat mass, body weight, muscle mass, BMI, body fat percentage, right upper-limb muscle mass, left upper-limb muscle mass, trunk muscle mass, right lower-limb muscle mass, left lower-limb muscle mass, right upper-limb water content, left upper-limb water content, trunk water content, right lower-limb water content, and left lower-limb water content-and the percent change and absolute change in calf circumference. | — |
Contacts
Public ContactTomoaki Fukui
Kobe University Hospital
Outcome results
None listed