Progressive Resistance Training for the Improvement of Physical Function

NCT ID: NCT04247425

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-28
• Study Completion Date: 2021-09-01

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.

Conditions

Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care (resistance training, exercise counseling)

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.

Group Type: EXPERIMENTAL

Exercise Counseling

Intervention Type: OTHER

Receive instructional guidance

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Resistance Training

Intervention Type: OTHER

Complete progressive resistance training

Interventions

Exercise Counseling

Receive instructional guidance

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Resistance Training

Complete progressive resistance training

Intervention Type: OTHER

Other Intervention Names

Quality of Life Assessment; Strength Training

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)

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Lara Davis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lara E Davis

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

NCI-2019-05865

Identifier Type: REGISTRY

Identifier Source: secondary_id

SOL-19103-L

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00019942

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA069533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00019942

Identifier Type: -

Identifier Source: org_study_id