Recruiting

Lymfit

Sponsor:

McGill University

Code:

NCT05257785

Conditions

Lymphoma

Cancer Survivors

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

Lymfit exercise intervention

Waitlist control

Study Details

Brief summary:

This randomized control trial seeks to determine whether a tailored and supervised exercise program adopting mobile-health technology will be able to improve fitness and quality of life among lymphoma survivors.

Conditions

Lymphoma

Cancer Survivors

Study ID

NCT05257785

Start date

Jan 15, 2022

Status verified date

Apr, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. newly diagnosed lymphoma patients who received an initial diagnosis at the age of age 18-39,
2. approved by their hematologist as having no contra-indications to vigorous exercise,
3. receiving or has received chemotherapy with curative intent within the past 6 months,
4. own a cellular phone that is able to download the Fitbit app and to complete the study questionnaires online in either French or English, and
5. has an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom).

Exclusion Criteria:

1. The patient has contra-indications to vigorous exercise,
2. the patient doesn't want to wear a fitness tracker due to various concerns (as no Fitbit data could be collected).

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Lymfit exercise intervention

Participants randomized to the intervention group will be allocated a pre-registered Fitbit, a personalized exercise prescription designed by the kinesiologist, and 12 weeks of supervision by the kinesiologist.

other: Waitlist control

Participants will receive the exact same Lymfit exercise intervention 3 months after they consent to participate in the study.

Interventions

Lymfit exercise intervention

Participants randomized to this arm will be allocated a pre-registered Inspire II / Charge IV model Fitbit. The kinesiologist of the study will meet with the participants for a baseline fitness assessment. The kinesiologist will examine the baseline physical activity levels, fitness level and sedentary behaviours of the participants, to design a personalized exercise prescription. Within one week after the baseline fitness assessment, the kinesiologist will contact the participants to discuss the exercise prescription. Every two weeks there-after, the kinesiologist will follow up with the participants via videoconferencing to discuss their progress and to modify or advance their exercise prescriptions as needed. Participants will be followed-up at 6 months and 12 months.

Waitlist control

Participants will be contacted by the study kinesiologist for a baseline fitness assessment 3 months after they consent, participants will be given a Fitbit, a personalized exercise prescription and receive bi-weekly follow-ups for 12 weeks.

Primary outcome measure

  • Change of the exercise guideline as determined by comparing the active minutes captured in the Fitbit [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Christine Maheu, Ph.D.

514-616-5954christine.maheu@mcgill.ca

Locations

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3A 2A7

Contacts

Christine Maheu

5146165954christine.maheu@mcgill.ca

More Information

Sponsor

McGill University

Last update posted

Apr 5, 2024

Last verified

Apr, 2024

Keywords

  • Cancer survivorship
  • Quality of Life
  • Physical Activity
  • Fear of Recurrence
  • Randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by McGill University on 2024-04-05.