Prehabilitation for Patients Diagnosed With Blood Cancer and Treated With Al-logeneic Hematopoietic Stem Cell Transplantation (PrepAllo)

Rigshospitalet

Status: Enrolling

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Treatments: Dietary Supplement: Nutritional Support; Procedure: Usual care; Other: Resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT07341698

H-25053677

MS25-01447 (Other Grant/Funding Number)

Details and patient eligibility

About

Seventy-five percent of patients treated with hematopoietic stem cell transplants survive one-year post-transplantation. However, this intensive treatment is associated with prolonged hospitalizations and significant deconditioning. Pathophysiological changes in skeletal muscle mass and function have notable implications for disease progression and long-term prognosis. Patients frequently report substantial rehabilitation needs, though these needs are highly individualized and fluctuate over time, with musculoskeletal dysfunction and fa-tigue being the most common barriers to prehabilitation. Furthermore, at least 35% of cancer patients are found to have inadequate daily protein intake, which may hinder improve-ments in physical performance through prehabilitation. Several recent studies have demonstrated the safety and feasibility of exercise-based prehabilitation interventions during the pre-transplant period. However, no full-scale randomized controlled trial (RCT) has been conducted to date.

Full description

Evaluate the effectiveness of an individualized prehabilitation intervention in addition to usual care, compared to usual care alone on HRQoL, and secondary outcomes hospitalization, muscle mass and muscle function.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adult patients >18 years will be eligible for inclusion if they are scheduled for a allo-HSCT with at least four weeks before their scheduled transplantation date.

Exclusion criteria

• pregnancy
• physical or mental disabilities precluding test of muscle function
• inability to read and understand Danish or English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Usual care

Active Comparator group

Description:

The usual care group will receive standard care, including physio- and occupational therapy if admitted to the hospital, and potentially referral to rehabilitation in the municipality three months after transplantation.

Treatment:

Procedure: Usual care

Usual care plus the prehabilitation intervention

Experimental group

Description:

The prehabilitation group will in addition to usual care receive supervised individually tailored resistance training and optimized nutritional support

Treatment:

Other: Resistance training

Procedure: Usual care

Dietary Supplement: Nutritional Support