The Effect of Strength Training and Protein Supplementation in Old Pre-frail Individuals

Strength Training and Protein Supplementation in Pre-frail Elderly Individuals. Effects on Muscle Mass, Muscle Strength, Rate of Force Development and Functional Capacity

The aim of this study is to investigate the effects of a lower-body strength training regime combined with protein supplementation in pre-frail elderly individuals. Participants are randomized to a group performing three weekly sessions of heavy-load strength training for 10 weeks and receiving daily protein supplementation, or a non-training, non-supplemented control group. The endpoints are changes in body composition, the relative changes in different compartments of the quadriceps femoris muscles, and the relationships between changes in muscle mass, muscle thickness, strength, and functional capacity. The investigators hypothesize that 10 weeks of heavy load strength training and protein supplementation will elicit improvements in muscle mass, strength, and functional performance. Moreover, it is hypothesized that improvements in strength will correlate with the improvements in functional performance.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Other: Heavy-load strength training; Dietary supplement: Protein supplementation

Detailed Description

Aging is accompanied by a loss of muscle mass and strength. Because muscle strength is associated with functional performance in elderly individuals, various tasks of daily living is hampered by the overall decline. The consequence is a vicious circle, where inactivity caused by reduced functional capacity accelerates the loss of muscle mass, strength and physical function. The Short Physical Performance Battery (SPPB) is commonly used to assess functional capacity, where individuals with a score of 10 or less out of maximum 12 may be categorized as pre-frail. Because small-to-moderate limitations in functional status assessed by SPPB is associated with higher odds of losing future mobility, these individuals represent a group of great interest. Strategies to improve functional capacity in this population are therefore important. It is established that heavy-load strength training, alone or in combination with protein supplementation, can improve muscle mass, strength, and function in elderly individuals. However, most studies have focused on healthy older adults, and less is known about the effects of heavy-load strength training in pre-frail elderly individuals. Moreover, the extent to which training-induced gains in muscle mass and size are related to improvements in strength and functional capacity is still poorly understood, because few intervention studies in this population have quantified hypertrophy precisely. Hence, the aim of this study is to investigate the effects of 10 weeks of heavy load strength training, performed three times per week, on muscle mass (DXA scan), muscle thickness (ultrasound), muscle strength (dynamic and isometric), rate of force development, chair rise ability, and gait velocity. Participants are randomized to a group performing three weekly sessions of heavy-load strength training or a control group. In addition, to optimize gains in muscle mass and strength, the strength training group will receive daily protein supplementation throughout the intervention period. The investigators hypothesize that the intervention will improve muscle mass, muscle thickness and strength, and that improvements in muscle strength and rate of force development will be correlated with improvements in functional capacity.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0863
    • Norwegian School of Sport Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 75
• Short Physical Performance Battery (SPPB) score ≤ 10

Exclusion Criteria:

• Lactose intolerance
• Milk allergy
• Diseases or musculoskeletal disorders contraindicating training/testing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: Strength training + protein supplement; Heavy-load strength training, Protein supplementation	Other: Heavy-load strength training; Three weekly sessions of heavy-load strength training for 10 weeks; Other Names: Resistance exercise; Dietary supplement: Protein supplementation; Daily supplementation of 2 x 17 grams of milk protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength of m. Quadriceps Femoris	Maximal isometric muscle strength of m. quadriceps femoris (maximal voluntary contraction for the knee extensors)	Change from baseline at 10 weks
Muscle strength of m. quadriceps femoris	Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum)	Change from baseline at 10 weeks
Leg lean mass	Measured by Dual-energy X-ray Absorptiometry (DXA-scan)	Change from baseline at 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
m. Vastus Lateralis thickness	Measured by ultrasound	Change from baseline at 10 weeks
Total lean mass	Measured by Dual-energy X-ray Absorptiometry (DXA-scan)	Change from baseline at 10 weeks
Fat mass	Measured by Dual-energy X-ray Absorptiometry (DXA-scan)	Change from baseline at 10 weeks
Bone mineral density	Measured by Dual-energy X-ray Absorptiometry (DXA-scan)	Change from baseline at 10 weeks
m. Rectus Femoris thickness	Measured by ultrasound	Change from baseline at 10 weeks
m. Vastus Intermedius thickness	Measured by ultrasound	Change from baseline at 10 weeks
m. Vastus Medialis thickness	Measured by ultrasound	Change from baseline at 10 weeks
Isometric knee extension rate of force development (RFD max)	Measured during maximal voluntary contraction	Change from baseline at 10 weeks
Isometric knee extension force at 100 ms	Force at 100 ms during maximal voluntary contraction	Change from baseline at 10 weeks
Habitual gait velocity	Time (sec) to walk 6 meters at preferred gait speed	Change from baseline at 10 weeks
Five times chair-rise performance	Time (sec) to rise from a chair five times	Change from baseline at 10 weeks
Stair climbing	Time (sec) to climb a staircase	Change from baseline at 10 weeks
Diet assessment	24-hour diet recall interviews	Change from baseline at 10 weeks

Collaborators and Investigators

• Sponsor: Norwegian School of Sport Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 21, 2015
• Study Completion (Actual): December 21, 2015

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Strength training; Pre-frail
• Other Study ID Numbers: ST-PF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No