Blood Flow Restriction Training in Acute Geriatric Rehabilitation: A Randomized Controlled Trial on Its Effects and Safety in Hospitalized Older Adults.

NCT07291765 | Not Yet Recruiting

• 1 other identifier: 2025_A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Older adults have a reduced ability to build and maintain muscle mass due to age-related changes in the muscular system. The resulting sarcopenia can lead to a number of health problems and limitations, such as an increased risk of falling and reduced mobility, which can affect quality of life and increase the risk of disease. To increase muscle mass and strength, high-intensity resistance training with loads of 70 to 85% of the repetition maximum (1RM) is recommended. However, this type of training poses a major challenge in the rehabilitation sector, as there is also an increased risk of injury due to physical limitations in old age. According to current research, low-intensity occlusion training could therefore represent a safe and effective training alternative. The aim of this study is therefore to examine the feasibility and effects of blood flow restriction training (BFR) on general health in older adults in a rehabilitative setting.

Conditions

Sarcopenia in Elderly

Outcome Measures

Primary Outcomes (2)

• Muscle Strength

  Isometric Maximal Strength Test of the Knee Extensors (in kg)

  Pre-Rehabilitation to Post-Rehabilitation (after 2 weeks)

• Timed Up and Go Test

  The Timed Up and Go Test (TUG) is a widely used English-language assessment for measuring functional mobility and fall risk in older adults. It records the time required to stand up from a chair, walk three meters, turn around, and sit down again.

  Pre-Rehabilitation to Post-Rehabilitation (after 2 Weeks)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Blood-Flow-Restriction Training

Device: Stationary Bike + Blood-Flow-Restriction

Control Group

ACTIVE COMPARATOR

Sham-Blood-Flow-Restriction Training

Device: Stationary Bike + Sham-Blood-Flow-Restriction

Interventions

Stationary Bike + Blood-Flow-Restriction DEVICE

Cycling Intensity individualized + 60% LOP

Intervention Group

Stationary Bike + Sham-Blood-Flow-Restriction DEVICE

Cycling Intensity individualized + 20mmHg

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Adults \>65 years with a two week hospitalized acute rehabilitation after a fracture closed to the hip joint

You may not qualify if:

• Sickle Cell Anemia
• Iatrogenic changes of the vessels at the place of the tournqiuet application (e.g. Stents)

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

St. Marien-Hospital Köln

Cologne, North Rhine-Westphalia, 50668, Germany

Location

Central Study Contacts

Alexander Franz, Dr. med., B.Sc.

CONTACT

+491703750718; alexander.franz@ukbonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)