Rehabilitation After a Hip Fracture: the Effects of Dietary Protein and Exercise on Bone and Muscle Health and Quality of Life

Not Applicable

Recruiting

• Conditions: Hip Fractures

• Registration Number: NCT07036341
• Lead Sponsor: Wageningen University

Brief Summary

Hip fractures often lead to functional limitations, loss of independence, weight loss and decreased well-being. Only half of the patients regain their functional level and 24% die within the following year. Financial consequences are significant due to costly surgery and long-term care. Hip fracture incidence is expected to increase sharply due to the ageing population, reducing accessibility to and quality of rehabilitation care. Therefore, optimizing treatment is essential.

Previous protein and exercise studies showed improved muscle and bone health in healthy or frail community-dwelling older adults, but effects in older hip fracture patients are not known. Better rehabilitation may improve bone and muscle health, nutritional status, quality of life, lower costs and lower burden for healthcare.

The overall objective is to investigate the effectiveness, costs and cost-effectiveness of a protein-enriched diet and resistance exercise for 3 months compared to usual care on bone and muscle health, and quality of life in older adults recovering from an acute hip fracture.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2025-04
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-08
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical Functioning	Physical performance measurements will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.	The short physical performance battery (SPPB) is used to assess physcial functioning. This test is a performance test assessing lower extremity function using measures of gait speed (over 4 meter), standing balance, and lower extremity strength.

Secondary Outcome Measures

Name	Time	Method
Handgrip strength	Handgrip strength will be measured at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.	Handgrip strenght will be measured with a hand dynamometer (kg).
Inpatient rehabilitation time	Assessed at discharge from the rehabilitation centre (varies per participant, on average after 1 month).	Number of days the patient stayed in the rehabilitation centre.
Daily life functioning	Daily life functioning will be assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.	The Barthel Index of Activities of Daily Living will be used to assess daily life functioning.
Nutritional Status	This measurement will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.	The Mini Nutritional Assessment (MNA) will be used to evaluate nutritional status.
Costs	This will be assessed after 3 months.	Participants will use a cost diary to keep track of their health care use, out-of-pocket costs, and productivity losses. A health care use questionnaire based on the iMTA Medical Cost Questionnaire will be used, which includes cost categories that were deemed relevant for older adults (general practitioner, home care, informal care, dietitian, physiotherapist, occupational therapist, hospitalization, residential care, rehabilitation care, outpatient clinic, and medication use). Out-of-pocket costs includes sports club memberships, purchase of sport equipment, and other out-of-pocket payments related to the intervention. Productivity losses will be measured using questions from the Productivity Cost Questionnaire.
Muscle mass	The DEXA scans will be performed at baseline and after 3 months.	Muscle mass will be quantified using dual-energy X-ray absorptiometry (DEXA).
Bone Mineral Density	The quantitative ultrasound measurements will be performed at baseline and after 3 months.	Quantitative ultrasound (QUS) parameters of the calcaneus will be measured using the portable Achilles EXPII bone ultrasonometer.
Quality of life	Quality of life will be assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.	Quality of life will be assessed with the EQ5D-5L questionnaire.
Blood markers	Blood markers will be measured at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.	Blood markers P1NP, IGF-1, PTH and vitamin D will be measured in serum.

Trial Locations

Locations (2)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands

Gelderse Vallei Hospital; 🇳🇱 Ede, Netherlands