Clinical trial NCT03900962: Home-based Resistance Training for Adults With Severe Obesity
Official title: Effects of Adding Home-based Power Training to a Multidisciplinary Weight Management Service: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: Severe obesity
Exercise
Weight management
Resistance training
Power training
Physical function
Lead sponsor: University of Hull
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Detailed description: Severe obesity reduces muscle contractile function, which manifests as a diminished ability to perform activities of daily living. These functional impairments often lead to pain during movement and a decreased motivation to exercise.

In the United Kingdom (UK), specialist Tier 3 weight management services are provisioned for adults with severe obesity. Tier 3 services comprise a multidisciplinary team (MDT) of specialists and mainly adopt an educational approach, focusing on psychological therapy, dietary modification, pharmacotherapy and physical activity advice. However, current Tier 3 programmes do not specifically address the functional impairments imposed by obesity, which predisposes adults with severe obesity to musculoskeletal pain and pathology.

Adding supervised resistance training to MDT weight management programmes has been shown to improve functional capacity in adults with severe obesity. However, supervised interventions place considerable time and resource burdens on the service provider and patient, which may not be conducive to sustained participation. Obese individuals often report feeling too embarrassed to exercise in front of others and feel uncomfortable appearing in public wearing exercise clothing. Home-based exercise is a convenient alternative to supervised interventions and may promote similar functional adaptations.

Traditional resistance training typically involves sustained contractions at low to moderate velocities. While this method of training is effective for augmenting maximal strength production, which is executed at slow velocities, it may neglect the development of muscle power. This is problematic because lower-limb power has recently emerged as a critical determinant of function in adults with severe obesity.

Power training integrates a high-speed component into conventional resistance training exercises. Research in older adults has consistently shown that power training is superior to conventional slow-speed strength training for improving functionality. Preliminary evidence also exists supporting the superiority of power training in sarcopenic obese adults. Nevertheless, it is unknown whether home-based power training is feasible or effective when added to an MDT weight management programme.

The investigators recruited participants from a UK Tier 3 specialist weight management service. In a prospective, parallel groups, randomised design, participants were randomly allocated to a slow-speed strength training group or a high-speed power training group. Both groups completed a 12-week, individualised, home-based resistance training intervention (2x/week) with behavioural support. The high-speed power training group performed resistance exercises with maximal intended concentric velocity whereas the slow-speed strength training group maintained a slow (2-s) lifting speed. Outcomes were assessed at baseline, 3-month (post-intervention), and 6-month (follow-up) endpoints.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Lower-limb power (W)
timeFrame: 3-month endpoint
Secondary outcomes:
measure: Number of recruited participants
timeFrame: During the 13-month recruitment period
measure: Number of adverse events
timeFrame: During the 3-month intervention period
measure: Attrition rate
timeFrame: During the 3-month intervention period
measure: Number of patients lost to follow-up
timeFrame: 3-month and 6-month endpoints
measure: Number of exercise sessions completed
timeFrame: During the 3-month intervention period
measure: Body mass (kg)
timeFrame: 3-month and 6-month endpoints
measure: Waist and hip circumference (cm)
timeFrame: 3-month and 6-month endpoints
measure: Waist to hip ratio
timeFrame: 3-month and 6-month endpoints
measure: Six-minute walk test (m)
timeFrame: 3-month and 6-month endpoints
measure: Timed up-and-go (s)
timeFrame: 3-month and 6-month endpoints
measure: 30-s chair sit-to-stand test (s)
timeFrame: 3-month and 6-month endpoints
measure: Shoulder press and seated row one repetition maximums (kg)
timeFrame: 3-month and 6-month endpoints
measure: Lower-limb power (W)
timeFrame: 6-month endpoint
measure: Lower-limb movement velocity (m/s)
timeFrame: 3-month and 6-month endpoints
measure: Shoulder press velocity (m/s)
timeFrame: 3-month and 6-month endpoints
measure: Shoulder press power (W)
timeFrame: 3-month and 6-month endpoints
measure: EuroQol 5-level questionnaire (EQ-5D-5L)
timeFrame: 3-month and 6-month endpoints
measure: EuroQoL visual analogue scale (EQ-VAS)
timeFrame: 3-month and 6-month endpoints
measure: Obesity and Weight Loss Quality of Life Instrument (OWLQOL)
timeFrame: 3-month and 6-month endpoints
measure: Weight-related symptom measure (WRSM)
timeFrame: 3-month and 6-month endpoints
measure: Sessional heart rate (%)
timeFrame: During the 3-month intervention period
measure: Session duration (minutes)
timeFrame: During the 3-month intervention period
measure: Total number of repetitions during each resistance training session
timeFrame: During the 3-month intervention period
measure: Step count
timeFrame: During the 3-month intervention period
measure: Isometric mid-thigh pull (kg)
timeFrame: 3-month and 6-month endpoints
Other outcomes:
Locations:
Study officials:
affiliation: University of Hull
name: Rebecca V Vince, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.