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

NCT ID: NCT07291765

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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The study is a randomized controlled trial with a pre-post design. The setting is the premises of St. Marien Hospital in Cologne. Participants will be recruited from the geriatric rehabilitation patient base. Patients will be randomized into 2 groups. The intervention group will be randomly assigned to receive BRF training on an exercise trainer five times a week over a period of two weeks, while the control group will receive sham-BFR training.

Conditions

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Sarcopenia in Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control Group

Sham-Blood-Flow-Restriction Training

Group Type ACTIVE_COMPARATOR

Stationary Bike + Sham-Blood-Flow-Restriction

Intervention Type DEVICE

Cycling Intensity individualized + 20mmHg

Intervention Group

Blood-Flow-Restriction Training

Group Type EXPERIMENTAL

Stationary Bike + Blood-Flow-Restriction

Intervention Type DEVICE

Cycling Intensity individualized + 60% LOP

Interventions

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Stationary Bike + Blood-Flow-Restriction

Cycling Intensity individualized + 60% LOP

Intervention Type DEVICE

Stationary Bike + Sham-Blood-Flow-Restriction

Cycling Intensity individualized + 20mmHg

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Sickle Cell Anemia
* Iatrogenic changes of the vessels at the place of the tournqiuet application (e.g. Stents)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Alexander Franz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Marien-Hospital Köln

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Central Contacts

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

Role: CONTACT

Phone: +491703750718

Email: [email protected]

Facility Contacts

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

Role: primary

Other Identifiers

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2025_A

Identifier Type: -

Identifier Source: org_study_id