Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT.

NCT ID: NCT04922970

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2022-04-30

Brief Summary

Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. However, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as low muscle mass, cardiovascular disease and diabetes. Conditions known from the older generations of the general population and also conditions highly related to lifestyle factors in the general population.

In the group of survivors after bone marrow transplantation, the cause for these late effects is not fully understood, as the same close association to lifestyle factors as seen in the general population, is not present in this group. Multiple studies have examined the possible causes, and it have been shown that certain elements of a bone marrow transplantation, ie. total body irradiation, are associated with the risk of developing late effects. As the cause is not fully understood, it is not known whether the treatment and preventive strategies, that would be applied in the general population for these conditions, are effective in this group.

Therefore, in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood.

The investigators will invite a group of persons, transplanted during childhood, as well as an age- and sex-matched control group to participate in the study. Both groups will go through a 16-week strength training intervention, and a thorough health examination before and after the intervention, to assess metabolic status and body composition.

If the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons, treated with bone marrow transplantation during childhood, it will support the implementation of structured training programs in the follow-up of these patients. Thereby hopefully contributing to an increased quality of life, as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood.

Conditions

Stem Cell Transplant; Late Effect; Metabolic Syndrome; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Strength training

In this arm participants will go through the "Strength training intervention".

Group Type: EXPERIMENTAL

Strength training

Intervention Type: OTHER

The interventon consist of 3 weekly, supervised group sessions for 4 months (16 weeks). The sessions consist of progressive full body strength training with a primary focus on lower extremity muscle strength. The leg exercises are leg press, knee extension and leg curl. In addition, participants will perform two upper body exercises. Physical assessment will take place immediately and monthly until 4 months.

Interventions

Strength training

The interventon consist of 3 weekly, supervised group sessions for 4 months (16 weeks). The sessions consist of progressive full body strength training with a primary focus on lower extremity muscle strength. The leg exercises are leg press, knee extension and leg curl. In addition, participants will perform two upper body exercises. Physical assessment will take place immediately and monthly until 4 months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Living in Copenhagen, Denmark or surrounding area - making it possible to engage in strength training 3 times a week at Bispebjerg Hospital, Copenhagen, Denmark.
• ≥ 18 years old

Exclusion Criteria

• Illness or physical handicap making it impossible to participate in the training intervention
• Pregnancy
• Not Danish or English speaking
• Anemia
• Already performing regular structured physical training
• Strict vegan or vegetarian diet
• Illness or ongoing treatment that hinders study examinations

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: collaborator

Danish Child Cancer Foundation

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

The Danish Cancer Research Foundation

UNKNOWN

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Klaus Gottlob Müller

Professor, Senior consultant, Doctor of Medical Science and ph.d.

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Krogh LM, Nissen A, Weischendorff S, Hartmann B, Andersen JL, Holst JJ, Sorensen K, Fridh MK, Mackey AL, Muller K. Bone remodeling in survivors of pediatric hematopoietic stem cell transplantation: Impact of heavy resistance training. Pediatr Blood Cancer. 2024 Sep;71(9):e31159. doi: 10.1002/pbc.31159. Epub 2024 Jul 2.

Reference Type: DERIVED

PMID: 38953152 (View on PubMed)

Other Identifiers

STEPS

Identifier Type: -

Identifier Source: org_study_id