NCT03900962

Brief Summary

This study evaluates whether adding home-based resistance training to a multidisciplinary specialist weight management service can promote weight loss and improve physical function, strength, power and quality of life in adults with severe obesity. The study also investigated whether performing resistance exercises as fast as possible can yield further improvements in physical function compared with traditional slow-speed resistance training. All recruited participants completed a 3-month home-based resistance training programme with behavioural support; half of the participants performed resistance exercises in a slow and controlled manner, whereas the other half performed resistance exercises with maximal intentional velocity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

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

Study Start

First participant enrolled

January 9, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

March 28, 2019

Last Update Submit

August 23, 2023

Conditions

Keywords

Severe obesityExerciseWeight managementResistance trainingPower trainingPhysical function

Outcome Measures

Primary Outcomes (1)

  • Lower-limb power (W)

    Mean power was measured in the sit-to-stand transfer with a wearable inertial sensor (PUSH, PUSH Inc., Toronto, Canada). The device is worn on the participant's forearm and measures acceleration in the upwards phase of the movement. Power is then calculated as velocity x force, where velocity is the integral of acceleration, and force is the product of mass and acceleration. The test was administered in a firm bariatric chair (height, 48 cm; depth, 56 cm; width, 69 cm). From a seated position, participants were instructed to maintain their arms crossed against their chest and stand up as quickly as possible (legs straight), before returning back to the initial seated position in a controlled manner (full weight on chair). Two warm-up trials were performed, followed by three repetitions separated by 60 seconds of rest. Additional trials were performed if the arms moved away from the chest.

    3-month endpoint

Secondary Outcomes (25)

  • Number of recruited participants

    During the 13-month recruitment period

  • Number of adverse events

    During the 3-month intervention period

  • Attrition rate

    During the 3-month intervention period

  • Number of patients lost to follow-up

    3-month and 6-month endpoints

  • Number of exercise sessions completed

    During the 3-month intervention period

  • +20 more secondary outcomes

Study Arms (2)

Slow-speed strength training

EXPERIMENTAL

The slow-speed strength training group performed the concentric phase of each resistance exercise over two seconds, paused at full extension/flexion for one second, and then performed the eccentric phase for two seconds.

Other: Home-based resistance trainingOther: Walking intervention

High-speed power training

EXPERIMENTAL

During the first three weeks of training, the high-speed power training group completed the concentric phase of each resistance exercise over two seconds, paused at full extension/flexion for one second, and then performed the eccentric phase for two seconds. Thereafter, this group completed the concentric phase of five resistance exercises (squat, press-up, incline chest press, seated row and push-press) as fast as possible whilst still taking two seconds to complete the eccentric phase.

Other: Home-based resistance trainingOther: Walking intervention

Interventions

Patients completed two home-based resistance training sessions each week on non-consecutive days for 12 weeks. The programme was delivered online via individual playlists on Youtube (YouTube, San Bruno, California, USA), with each playlist involving an individually-prescribed series of pre-recorded exercise videos. Each session involved a dynamic warm-up followed by 11 resistance exercises using body weight and resistance bands, and finished with static stretching. Participants completed 1-2 sets of 5-12 repetitions at 4-7 on a modified 10-point rating of perceived exertion scale, which corresponded to qualitative descriptors of "moderate" to "hard". Resistance training stimuli were progressed weekly by increasing the external load, modifying the exercise selection, increasing the number of repetitions, and/or increasing the number of sets.

High-speed power trainingSlow-speed strength training

After the initial baseline assessment, participants recorded the number of steps they walked daily for seven days using a waist-worn pedometer. Participants maintained their usual physical activity levels during this period. Participants were then encouraged to increase their total steps walked each day by 5% each week during the 12-week intervention.

High-speed power trainingSlow-speed strength training

Eligibility Criteria

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

You may qualify if:

  • Currently enrolled in a Tier 3 specialist weight management service in the United Kingdom
  • Body mass index of ≥ 40 kg/m2 or between 35 and 40 kg/m2 with a serious co-morbidity (such as type 2 diabetes or obstructive sleep apnoea).
  • Aged ≥ 18 years
  • Willing and able to give written informed consent.
  • Understand written and verbal instructions in English

You may not qualify if:

  • Unstable chronic disease state
  • Prior myocardial infarction or heart failure
  • Poorly controlled hypertension (≥ 180/110 mmHg)
  • Uncontrolled supraventricular tachycardia (≥ 100 bpm)
  • Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine
  • Current participation in a structured exercise regime (≥ 2x/week for the last 3 months)
  • Body mass ≥ 200 kg
  • Any pre-existing musculoskeletal or neurological condition that could affect their ability to complete the training and testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Ling C, Kelechi T, Mueller M, Brotherton S, Smith S. Gait and Function in Class III Obesity. J Obes. 2012;2012:257468. doi: 10.1155/2012/257468. Epub 2012 Feb 16.

    PMID: 22496967BACKGROUND
  • Shultz SP, Byrne NM, Hills AP. Musculoskeletal Function and Obesity: Implications for Physical Activity. Curr Obes Rep. 2014 Sep;3(3):355-60. doi: 10.1007/s13679-014-0107-x.

    PMID: 26626767BACKGROUND
  • Brown TJ, O'Malley C, Blackshaw J, Coulton V, Tedstone A, Summerbell C, Ells LJ. Exploring the evidence base for Tier 3 weight management interventions for adults: a systematic review. Clin Obes. 2017 Oct;7(5):260-272. doi: 10.1111/cob.12204. Epub 2017 Jul 10.

    PMID: 28695579BACKGROUND
  • Herring LY, Wagstaff C, Scott A. The efficacy of 12 weeks supervised exercise in obesity management. Clin Obes. 2014 Aug;4(4):220-7. doi: 10.1111/cob.12063. Epub 2014 Jun 26.

    PMID: 25826793BACKGROUND
  • Baillot A, Mampuya WM, Comeau E, Meziat-Burdin A, Langlois MF. Feasibility and impacts of supervised exercise training in subjects with obesity awaiting bariatric surgery: a pilot study. Obes Surg. 2013 Jul;23(7):882-91. doi: 10.1007/s11695-013-0875-5.

    PMID: 23430477BACKGROUND
  • Wiklund M, Olsen MF, Willen C. Physical activity as viewed by adults with severe obesity, awaiting gastric bypass surgery. Physiother Res Int. 2011 Sep;16(3):179-86. doi: 10.1002/pri.497. Epub 2010 Nov 9.

    PMID: 21061456BACKGROUND
  • Orange ST, Marshall P, Madden LA, Vince RV. Short-Term Training and Detraining Effects of Supervised vs. Unsupervised Resistance Exercise in Aging Adults. J Strength Cond Res. 2019 Oct;33(10):2733-2742. doi: 10.1519/JSC.0000000000002536.

    PMID: 29528961BACKGROUND
  • Orange ST, Marshall P, Madden LA, Vince RV. Can sit-to-stand muscle power explain the ability to perform functional tasks in adults with severe obesity? J Sports Sci. 2019 Jun;37(11):1227-1234. doi: 10.1080/02640414.2018.1553500. Epub 2018 Dec 5.

    PMID: 30517830BACKGROUND
  • Steib S, Schoene D, Pfeifer K. Dose-response relationship of resistance training in older adults: a meta-analysis. Med Sci Sports Exerc. 2010 May;42(5):902-14. doi: 10.1249/MSS.0b013e3181c34465.

    PMID: 19996996BACKGROUND
  • Tschopp M, Sattelmayer MK, Hilfiker R. Is power training or conventional resistance training better for function in elderly persons? A meta-analysis. Age Ageing. 2011 Sep;40(5):549-56. doi: 10.1093/ageing/afr005. Epub 2011 Mar 7.

    PMID: 21383023BACKGROUND
  • Balachandran A, Krawczyk SN, Potiaumpai M, Signorile JF. High-speed circuit training vs hypertrophy training to improve physical function in sarcopenic obese adults: a randomized controlled trial. Exp Gerontol. 2014 Dec;60:64-71. doi: 10.1016/j.exger.2014.09.016. Epub 2014 Oct 1.

    PMID: 25281504BACKGROUND
  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

    PMID: 12091180BACKGROUND
  • Orange ST, Metcalfe JW, Liefeith A, Marshall P, Madden LA, Fewster CR, Vince RV. Validity and Reliability of a Wearable Inertial Sensor to Measure Velocity and Power in the Back Squat and Bench Press. J Strength Cond Res. 2019 Sep;33(9):2398-2408. doi: 10.1519/JSC.0000000000002574.

    PMID: 29742745BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Rebecca V Vince, PhD

    University of Hull

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The investigator and outcome assessors were not blind to group allocation. It was also not possible to blind participants to the intervention, however, patients were unaware of the study hypotheses.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After baseline measures were collected, participants were randomly allocated (1:1) to the slow-speed strength training group or the high-speed power training group in block sizes of four using a randomisation sequence created by an independent researcher (GraphPad QuickCalcs, Graphad Software, La Jolla, CA).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 3, 2019

Study Start

January 9, 2017

Primary Completion

May 18, 2018

Study Completion

August 24, 2018

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

All raw data and imputed data will be made available via the open science framework (https://osf.io/)

Shared Documents
SAP, ANALYTIC CODE
Time Frame
Immediately after publication
Access Criteria
Raw data will be made available to the public without restriction.