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High Intensity Functional Training in the Rehabilitation of Cancer Survivors

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ClinicalTrials.gov Identifier: NCT04001127
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Andreas Lund Hessner, University of Copenhagen

Brief Summary:

The primary aim of this study is to investigate changes in health related quality of life (HRQoL) and cancer-related fatigue (CRF) following a 16-weeks of HIFT as a part of the rehabilitation of cancer survivors.

Additionally, we will investigate the continuation of participation in any High Intensity Functional Training (HIFT) program, three as well as 12 months following completion of the exercise intervention.

The intervention containing high intensity functional training will take place in a pragmatic clinical setting at the Center for Cancer and Health in Copenhagen.

We hypothesize that the HIFT will be be associated with improved HRQoL and CRF.


Condition or disease Intervention/treatment Phase
Cancer Other: High Intensity Functional Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a single group clinical trial. A pragmatic design will be applied for this study as participants will be included consecutively as they are referred to the Center for Cancer and Health Copenhagen for cancer rehabilitation and agrees to participate in the study.
Masking: None (Open Label)
Masking Description: No masking.
Primary Purpose: Treatment
Official Title: High Intensity Functional Training in the Rehabilitation of Cancer Survivors: A Protocol for a Pragmatic Clinical Trial
Actual Study Start Date : August 6, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity Functional Training
Intervention group assigned to 16 weeks of group-based high intensity functional training supervised by physiotherapists.
Other: High Intensity Functional Training
The exercise intervention for this study will be HIFT, defined as a style of training that incorporates functional, multimodal movements, performed at relatively high intensity, and designed to improve parameters of general physical fitness and performance. The program design and template will be based on the principles of the HIFT program called CrossFit®. CrossFit is described as a strength and conditioning program that focuses on "constantly varying functional movements, performed at a relatively high intensity". CrossFit training includes a variety of elements from gymnastics (e.g., floor, bar and ring exercises), weightlifting exercises (e.g., squats, cleans, snatches and presses with a barbell, dumbbell or kettlebell), and cardiovascular activities (e.g., running or rowing).




Primary Outcome Measures :
  1. Health related quality of life [ Time Frame: For each participant at baseline + end point at 16 weeks + follow up at 3 month and 12 months) ]

    Change in HRQoL from baseline to end point and from end point to follow up at 3 and 12 months, will be evaluated using the Global Health Status/Quality of Life item from the EORTC QLQ-C-30 questionnaire.

    EORTC QLQ-C-30 includes five functional domains (physical, role, cognitive, emotional and social, where higher scores represent greater function or quality of life) and three symptom scales (fatigue, pain and nausea). Functional and symptom scales range from 0 to 100. Higher values on functional scales equal a higher level of functioning. Higher values on symptom scales equal higher symptom burden. EORTC QLQ-C-30 is chosen for it's established reliability and validity with specific emphasis on use in cancer populations



Secondary Outcome Measures :
  1. Symptoms and function [ Time Frame: For each participant at baseline + end point at 16 weeks + follow up at 3 month and 12 months) ]
    The secondary outcomes include functional scales (physical, role, emotional, cognitive, and social) and symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) from the EORTC QLQ-C30 questionnaire (ref: Fayes 2001).

  2. Leisure time physical activity level [ Time Frame: Time frame for each participant: Baseline + end point at 16 weeks + follow up at 3 months and 12 months ]

    Leisure time physical activity (LTPA) will be assessed using an original Danish translation of the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) .The GSLTPAQ is frequently used in oncology research to assess LTPA.

    The GSLTPAQ is a 4-item self-administered questionnaire. The first three questions ask for information on the number of times the respondant engages in mild, moderate and strenuous LTPA bouts of at least 15 min duration in a typical week. A score is then calculated for total leisure time based on the numerical values attributed to each of the three categories (9 for strenuous, 5 for moderate and 3 for light) multiplied by the frequency of the activity. The scores derived from this method is called a Leisure Score Index (LSI). In addition, scores obtained from moderate and strenuous physical activity can be used to classify respondents into active and insufficiently active categories.


  3. Continued participation in high intensity functional training (post-intervention) [ Time Frame: Time frame: for each participant at follow up at 3 month and 12 months ]
    Continued participation in any high intensity functional training (post-intervention HIFT) will be assessed using a single-item modified version of the (GSLTPAQ) asking participants: During a typical 7-Day period (a week), how many times on the average do you do High Intensity Functional Training (I.E. CrossFit) for more than 15 minutes during your free time. The participant responds by typing how many times per week, starting from zero.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Due to the pragmatic design of this study, only few inclusion- and exclusion criteria will be applied.

The inclusion citeria are

  • Patients must be at least 18 years old
  • Patients referred to the centre for cancer rehabilitation from any hospital or private practising general practitioner in the Capital Region in Denmark
  • Patients who choose to participate in group based high intensity functional training that is offered at CCHC as part of their physical rehabilitation.

Eligibility for participation in this study will be regardless of cancer treatment and the stage of the cancer. Thus, both patients undergoing active cancer treatment, patient who have completed active treatment as well as chronic cancer survivors will be considered eligible for participation in this study.

The following exclusion criteria will be applied for this study:

  • Patients not able to reply to the questionnaire due to mental impairment
  • Patients who are not able to read and understand Danish
  • Patients who does not have an e-mail address because of the application of online-based questionnaires.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001127


Contacts
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Contact: Andreas Lund Hessner, Msc. 004551964161 hessnerfysioterapi@gmail.com
Contact: Rasmus Tolstrup Larsen, Msc. 004542423007 rala@sund.ku.dk

Locations
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Denmark
Center for Cancer and Health Copenhagen Recruiting
Copenhagen, København N, Denmark, 2200
Contact: Rikke Ms. Daugaard, Msc.    004560298225    ZH62@kk.dk   
Contact: Jette Ms. Vibe-Petersen, MD    004526373729    PF83@kk.dk   
Sponsors and Collaborators
Andreas Lund Hessner
  Study Documents (Full-Text)

Documents provided by Andreas Lund Hessner, University of Copenhagen:

Publications:
Bechke E, Kliszczewicz B, Feito Y, Kelemen H, Nickerson B. Resting cardiac autonomic activity and body composition following a 16-week high-intensity functional training intervention in women: A pilot study. Journal of Human Sport & Exercise. 2017 Jul;12(3):680-8.

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Responsible Party: Andreas Lund Hessner, Principal investigator, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04001127     History of Changes
Other Study ID Numbers: 514-0306/19-3000
H-19010858 ( Other Identifier: Danish Regional Scientific Ethics Committee )
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Lund Hessner, University of Copenhagen:
high intensity functional training
crossfit
cancer survivors