NCT04554667

Brief Summary

The LIFTING trial will examine the feasibility and safety of a heavy lifting strength training (HLST) program in head and neck cancer survivors (HNCS) at least 1 years post surgical neck dissection. The trial will determine whether this training style is safe and feasible in HNCS. Physical and psychosocial changes will also be reported.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 24, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

September 11, 2020

Last Update Submit

September 2, 2022

Conditions

Keywords

surgeryneck dissectionstrength trainingsurvivorsexercise

Outcome Measures

Primary Outcomes (3)

  • Recruitment Rate

    Recruitment rate (with reasons for refusal). Recruitment minimum: 15 participants Recruitment maximum: 20 participants Higher number= better and more data

    Over 12 weeks

  • Muscular Strength

    Change in muscular strength from baseline to postintervention with be assessed using maximal strength tests. Minimum: none Maximum: none Higher score= better strength

    Changes from baseline to 12 weeks

  • Program Adherence

    Program adherence minimum: 80% Program adherence maximum: 100% Higher score= better adherence

    Over 12 weeks

Secondary Outcomes (15)

  • Physical functioning

    Changes from baseline to 12 weeks

  • Fear of cancer recurrence

    Changes from baseline to 12 weeks

  • Post Traumatic Growth after cancer

    Changes from baseline to 12 weeks

  • Waist to hip ratio (body composition)

    Changes from baseline to 12 weeks

  • Anxiety

    Changes from baseline to 12 weeks

  • +10 more secondary outcomes

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Single exercise arm

Behavioral: Exercise Intervention

Interventions

Heavy Lifting Strength Training

Exercise Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • previously diagnosed with any subtype and stage of head and neck cancer
  • at least one year post surgical neck dissection for head and neck cancer and showing full shoulder range of motion or recovery of the spinal accessory nerve
  • adults ages 18 and older
  • no unmanaged medical conditions, alcohol, and drug abuse
  • approved for a heavy lifting strength training program by the treating surgeon and a certified exercise physiologist
  • ability to understand and communicate in English

You may not qualify if:

  • having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2H9, Canada

Location

Related Publications (1)

  • Ntoukas SM, McNeely ML, Seikaly H, O'Connell D, Courneya KS. Feasibility and safety of Heavy Lifting Strength Training in Head and Neck Cancer survivors post-surgical neck dissection (the LIFTING trial). Support Care Cancer. 2023 May 22;31(6):348. doi: 10.1007/s00520-023-07815-2.

MeSH Terms

Conditions

Head and Neck NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBehavior

Study Officials

  • Kerry S Courneya, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single arm, safety and feasibility trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 18, 2020

Study Start

November 24, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

September 6, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations