Progressive Resistance Training for the Improvement of Physical Function

NCT04247425 | Completed Results DMC

• 4 other identifiers: STUDY00019942NCI-2019-05865SOL-19103-LP30CA069533
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (3)

• Retention

  Number of evaluable participants who completed end-of-intervention assessments

  From the time of enrollment up to 3 months end-of-intervention assessments

• Exercise Adherence

  Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions.

  From the time of enrollment up to completion of 12 week exercise intervention

• Frequency of Related Serious Adverse Events (SAEs)

  Number of participants that experienced exercise-related SAEs

  From the time of enrollment up to completion of 12 week exercise intervention

Secondary Outcomes (12)

• Individualized Progressive Resistance Training (PRT) Prescriptions

  From the time of enrollment up to completion of 12 week exercise intervention

• Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value

  Baseline up to completion of 12 week exercise intervention

• Change in Short Form-36 Physical Function Score

  Baseline up to completion of 12 week exercise intervention

• Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ)

  Baseline up to completion of 12 week exercise intervention

• Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F)

  Baseline up to completion of 12 week exercise intervention

Study Arms (1)

Supportive Care (resistance training, exercise counseling)

EXPERIMENTAL

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.

Other: Exercise Counseling; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training

Interventions

Exercise Counseling OTHER

Receive instructional guidance

Supportive Care (resistance training, exercise counseling)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (resistance training, exercise counseling)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (resistance training, exercise counseling)

Resistance Training OTHER

Complete progressive resistance training

Also known as: Strength Training

Supportive Care (resistance training, exercise counseling)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The COVID pandemic resulted in extensive protocol revisions to pivot from in person assessments to telehealth. Multiple secondary endpoints were therefore not collected

Results Point of Contact

• Title: Lara Davis, MD
• Organization: Oregon Health & Science University

davisla@ohsu.edu

5034948423

Study Officials

• Lara E Davis

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 30, 2020
• Study Start: June 28, 2019
• Primary Completion: January 1, 2021
• Study Completion: September 1, 2021
• Last Updated: August 8, 2022
• Results First Posted: August 8, 2022

Record last verified: 2022-07

Locations

US (1)