N/A
N=10
Progressive Resistance Training for the Improvement of Physical Function
Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT04247425 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Retention — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise Counseling (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Resistance Training (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention |
9 | — |
| PRIMARY Exercise Adherence |
7 | — |
| PRIMARY Frequency of Related Serious Adverse Events (SAEs) |
— | — |
| SECONDARY Individualized Progressive Resistance Training (PRT) Prescriptions |
10 | — |
| SECONDARY Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value |
45.6; 47.2 | 0.59 |
| SECONDARY Change in Short Form-36 Physical Function Score |
43.3; 49.1 | 0.02 sig |
| SECONDARY Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ) |
28.6; 20.8 | 1.0 |
| SECONDARY Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F) |
30.2; 40.1 | 0.09 |
| SECONDARY Difference in 1-repetition Maximum (Kilogram) |
— | — |
| SECONDARY Change in Short Physical Performance Battery Score |
— | — |
| SECONDARY Change in Grip Strength (Kilogram) |
— | — |
| SECONDARY Change in Gait and Balance |
— | — |
| SECONDARY Change in Instrumented 6-minute Walk Test |
— | — |
| SECONDARY Change in Instrumented Postural Sway |
— | — |
| SECONDARY Change in Instrumented Timed up and go Test |
— | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04247425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.