Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289049
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-02-22
Brief Title:
Heavy Strength Training in Head and Neck Cancer Survivors
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training Versus Usual Care in Head and Neck Cancer Survivors A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIFTING2
Brief Summary:
Despite improvements in treatments head and neck cancer survivors HNCS still endure acute and chronic side effects such as loss of muscular strength limitations in physical functioning fatigue and swallowing difficulties that impact quality of life QoL and limit return to work Light-to-moderate intensity strength training LMST has been shown to improve some side effects Heavy lifting strength training HLST may further improve outcomes in some populations however only one small pilot study has focused on HNCS The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS
Detailed Description:
1 Background and Rationale
Despite improvements in treatments head and neck cancer survivors HNCS still endure acute and chronic side effects such as loss of muscular strength limitations in physical functioning fatigue and swallowing difficulties that impact quality of life QoL and limit return to work Light-to-moderate intensity strength training LMST has been shown to improve some side effects Heavy lifting strength training HLST may further improve outcomes in some populations however only one small pilot study has focused on HNCS
2 Research Question Objectives
The primary aim of the proposed study is to further establish the feasibility of HLST in HNCS which will be based on the eligibility rate recruitment rate one-repetition max 3RM testing rate HLST program adherence and follow-up assessment rate A secondary aim is to provide preliminary evidence of the effects of a HLST program compared to usual care UC in HNCS The primary efficacy outcome will be upper and lower muscular strength assessed by reliable 3-repetition maximum 3RM tests on the chest press and leg press machines Secondary efficacy outcomes include physical function handgrip strength body composition QoL fear of cancer recurrence symptom burden pain anxiety fatigue stress self-esteem shoulder mobility sleep malnutrition status and swallowing abilities
3 Methods
This single-centre two-armed randomized controlled trial will recruit 60 HNCS 1-year posttreatment and randomly assign them to the HLST group or UC group For the HLST group the 12-week exercise intervention will include supervised training 2 days per week The HLST group will progress to lifting low repetitions of heavy loads at 80-90 of one repetition maximum 1RM whereas the UC group will not receive any exercise prescription or instruction during the 12-week intervention but will be offered a 4-week introduction to HLST program andor referred to a community-based program after the postintervention assessments are complete Assessments for both groups will occur at baseline and postintervention and include reliable 3RM strength tests bioelectrical impedance analysis BIA Seniors Fitness Test and validated QoL questionnaires
Despite improvements in treatments head and neck cancer survivors HNCS still endure acute and chronic side effects such as loss of muscular strength limitations in physical functioning fatigue and swallowing difficulties that impact quality of life QoL and limit return to work Light-to-moderate intensity strength training LMST has been shown to improve some side effects Heavy lifting strength training HLST may further improve outcomes in some populations however only one small pilot study has focused on HNCS
2 Research Question Objectives
The primary aim of the proposed study is to further establish the feasibility of HLST in HNCS which will be based on the eligibility rate recruitment rate one-repetition max 3RM testing rate HLST program adherence and follow-up assessment rate A secondary aim is to provide preliminary evidence of the effects of a HLST program compared to usual care UC in HNCS The primary efficacy outcome will be upper and lower muscular strength assessed by reliable 3-repetition maximum 3RM tests on the chest press and leg press machines Secondary efficacy outcomes include physical function handgrip strength body composition QoL fear of cancer recurrence symptom burden pain anxiety fatigue stress self-esteem shoulder mobility sleep malnutrition status and swallowing abilities
3 Methods
This single-centre two-armed randomized controlled trial will recruit 60 HNCS 1-year posttreatment and randomly assign them to the HLST group or UC group For the HLST group the 12-week exercise intervention will include supervised training 2 days per week The HLST group will progress to lifting low repetitions of heavy loads at 80-90 of one repetition maximum 1RM whereas the UC group will not receive any exercise prescription or instruction during the 12-week intervention but will be offered a 4-week introduction to HLST program andor referred to a community-based program after the postintervention assessments are complete Assessments for both groups will occur at baseline and postintervention and include reliable 3RM strength tests bioelectrical impedance analysis BIA Seniors Fitness Test and validated QoL questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None