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

NCT04922970 | Unknown

• 1 other identifier: STEPS
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Keywords

Strength training; Resistance training

Outcome Measures

Primary Outcomes (2)

• Changes in cross sectional area of m. quadricpes femoris.

  Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.

  1 week pre intervention

• Changes in cross sectional area of m. quadricpes femoris.

  Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.

  1 week post intervention

Secondary Outcomes (26)

• Changes in components of the Metabolic Syndrome: Waist circumference

  1 week pre intervention

• Changes in components of the Metabolic Syndrome: Waist circumference

  1 week post intervention

• Changes in components of the Metabolic Syndrome: Triglycerides

  1 week pre intervention

• Changes in components of the Metabolic Syndrome: Triglycerides

  1 week post intervention

• Changes in components of the Metabolic Syndrome: HDL-cholesterol

  1 week pre intervention

Other Outcomes (52)

• Histology of thigh muscle

  1 week pre intervention

• Histology of thigh muscle

  1 week post intervention

• Body composition: Intraabdominal visceral fat

  1 week pre intervention

Study Arms (1)

Strength training

EXPERIMENTAL

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

Other: Strength training

Interventions

Strength training 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.

Strength training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Bispebjerg Hospital: collaborator
• Danish Child Cancer Foundation: collaborator
• University of Copenhagen: collaborator
• The Danish Cancer Research Foundation: collaborator

Related Publications (1)

• 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.

  PMID: 38953152 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior consultant, Doctor of Medical Science and ph.d.

Model Details: The same interventon will be applied to two groups, a group of previously recipients of bone marrow transplantation, and a group of age- and sex-matched controls.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 11, 2021
• Study Start: June 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 23, 2021

Record last verified: 2021-06