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Active, Not Recruiting

NCT Number: NCT06102876

Feasibility of Physical Activity in Older Adults With Haematological Malignancies: ACCES Study

The aim of this study is to implement a simple and unsupervised home-based physical activity (PA) program for cancer patients in 2 oncogeriatric units in Toulouse Hospital (day hospital and week hospital).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Toulouse

Toulouse, France

About this study

Cancer treatments can cause side effects such as fatigue and reduced muscle function. Studies have shown the benefits of physical activity, including reduced fatigue and improved quality of life. Moreover, PA is often recommended for cancer survivors rather than patients undergoing treatment. It is essential to develop adapted, unsupervised, home-based PA programs to ensure access to PA for all cancer patients, particularly those living in rural areas or who have difficulty accessing healthcare. The PA program CREATE is a simple, unsupervised PA program based on patients' functional capacities. Depending on the patient's functional capacity, one of 7 PA programs will be prescribed by the doctor. The patient must perform the program independently for 6 months. Telephone follow-ups (weeks 1, 2, 4, 6, 9, 12, 16, 20, et 24) as well as a monthly in-person follow-up visit will be made to adjust the prescription.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • suffering from a hematological malignancy (Myelodysplasia, Leukemia of any type, Lymphoma, Myeloma)
  • patient affiliated to a social security insurance
  • Patient undergoing or scheduled chemotherapy (< 3 months) and/or immunotherapy and/or targeted therapy.

Exclusion criteria

  • Life expectancy estimated at less than 3 months by the unit doctor;
  • Cognitive impairment (not allowing comprehension of the physical activity program and research project) defined by Mini-Mental State Examination (MMSE) <20/30;
  • Patient included in a clinical trial that potentially interferes with the study objective (geriatric interventional study, early drug study, study modifying the patient's lifestyle habits).;
  • Acute health problem (fever, severe anemia, intense pain, etc.) limiting the possibility of involvement in the program;
  • Contraindication to physical activity;
  • Patient under legal protection (guardianship or curatorship or safeguard of justice);
  • Refusal of patient or primary caregiver to participate.

Treatment and study plan

Physical activity (PA) program

Other

The PA program is specific for each patient according to their mobility profile assessed using a decision tree comprising 3 tests: 1) the number of repetitions in the 30-second sit-to-stand test, 2) the score in the Short Physical Performance Battery (SPPB) test and 3) grip strength. The PA program has to be performed once daily.

Primary outcomes

  1. Feasibility of the PA program

    Time frame: 6 months

    PA program is considered feasible if at least 50% of them complete at least 70% of the prescribed sessions. Adherence is recorded in a logbook (every day), during the usual follow-up at the hospital (every month) and during telephone follow-up (weeks 1, 2, 4, 6, 9, 12, 16, 20, et 24).

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Feasibility of Physical Activity in Older Adults With Haematological Malignancies: ACCES Study (Aging & CanCer : Exercise as a Solution)

Acronym: ACCES

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2023
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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