Clinical trial NCT04247425: Progressive Resistance Training for the Improvement of Physical Function
Official title: A Resistance Training Program to Improve Physical Function in Sarcoma Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Oregon Health and Science University
First posted: 2020-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well progressive resistance training works in improving the physical function of sarcoma survivors. Treatments for sarcoma can cause side effects such as fatigue, muscle loss, and weakness, which can negatively impact a patient's ability to physically function and enjoy an independent lifestyle. Engaging in a resistance training exercise routine may improve physical function, body composition, and bone density of sarcoma survivors.

Detailed description: PRIMARY OBJECTIVE:

I. To determine the feasibility of a home-based individualized progressive resistance training (PRT) program in sarcoma survivors.

SECONDARY OBJECTIVES:

I. To assess secondary measures of feasibility of a home-based, individualized PRT program in sarcoma survivors.

II. To determine if a 3-month PRT program improves physical function in sarcoma survivors.

EXPLORATORY OBJECTIVE:

I. To determine if a 3 month resistance training program improves body composition and bone mineral density.

OUTLINE:

Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks.

After completion of study, patients are followed up at 3 months.

Eligibility criteria: Inclusion Criteria:

* Eligible for the Sarcoma Survivorship Registry (Institutional Review Board \[IRB\] #12039)

  * History of histologically-confirmed sarcoma
  * History of treatment with surgery, radiation and/or chemotherapy for the sarcoma diagnosis
  * Completion of sarcoma treatment \>= 2 years prior to study enrollment
  * No evidence of recurrent or residual disease on surveillance exam or imaging for at least 2 years prior to study enrollment
* Sarcoma location must have been in the extremities, body wall, pelvic/shoulder girdle or axial skeleton. Intra-thoracic, intra-abdominal or cranial sarcomas are not eligible
* Currently engaging in \< 1 hour of resistance exercise per week by self-report. Examples of resistance exercise include: using free weights or weight machines, push-ups, sit-ups, lunges, plank, etc.
* Able and willing to commit to attending weekly video coaching sessions and independently completing weekly resistance training sessions. This requires access to internet and a device with video and audio capabilities. A webcam may be provided by the study to the participant if needed
* Able and willing to commit to attending one initial in-person training session and one in-person follow-up assessment
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Medical contraindication(s) to any and all resistance training as determined by treating physician
* Non-English speaking. At this time, we do not have resources to support translation of exercise physiologist (EP) sessions
* Dependent on a mobility device (e.g., crutches, wheelchair) for independent activities of daily living (IADLs)

  * Use of a cane is permitted
* Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results (e.g., pregnancy)

Primary outcomes:
measure: Retention
timeFrame: From the time of enrollment up to 3 months end-of-intervention assessments
measure: Exercise Adherence
timeFrame: From the time of enrollment up to completion of 12 week exercise intervention
measure: Frequency of Related Serious Adverse Events (SAEs)
timeFrame: From the time of enrollment up to completion of 12 week exercise intervention
Secondary outcomes:
measure: Individualized Progressive Resistance Training (PRT) Prescriptions
timeFrame: From the time of enrollment up to completion of 12 week exercise intervention
measure: Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value
timeFrame: Baseline up to completion of 12 week exercise intervention
measure: Change in Short Form-36 Physical Function Score
timeFrame: Baseline up to completion of 12 week exercise intervention
measure: Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ)
timeFrame: Baseline up to completion of 12 week exercise intervention
measure: Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F)
timeFrame: Baseline up to completion of 12 week exercise intervention
measure: Difference in 1-repetition Maximum (Kilogram)
timeFrame: Baseline up to completion of 12 week exercise intervention
measure: Change in Short Physical Performance Battery Score
timeFrame: Baseline up to completion of 12 week exercise intervention
measure: Change in Grip Strength (Kilogram)
timeFrame: Baseline up to completion of 12 week exercise intervention
measure: Change in Gait and Balance
timeFrame: Baseline up to completion of 12 week exercise intervention
measure: Change in Instrumented 6-minute Walk Test
timeFrame: Baseline up to completion of 12 week exercise intervention
measure: Change in Instrumented Postural Sway
timeFrame: Baseline up to completion of 12 week exercise intervention
measure: Change in Instrumented Timed up and go Test
timeFrame: Baseline up to completion of 12 week exercise intervention
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Lara E Davis
role: PRINCIPAL_INVESTIGATOR
References: